Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
Phase: NA
Conditions: Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea, Adherence, Treatment, Motivation
Sponsor: University of Washington

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December 7, 2023 
 
 
Official Title: Optimizing adherence to the treatment of sleep apnea among 
patients with stroke undergoing inpatient rehabilitation 
 
NCT Number: STUDY00016907 
 
 
 

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Optimizing adherence to the treatment of sleep apnea among patients with 
stroke undergoing inpatient rehabilitation 
 
Stroke and CPAP Outcome Study 3 (SCOUTS 3) Protocol 
Background and rationale 
Stroke is the leading cause of adult, serious long-term disability in the United States.1 The burden of stroke- 
related impairments remains unacceptably high and few treatments are proven to improve recovery.2,3 An 
estimated 70% to 90% of stroke survivors have obstructive sleep apnea (OSA).4-6 Compared to those without 
OSA, stroke patients with OSA have worse recovery after inpatient rehabilitation (IPR),7,8 40% longer IPR 
stays,8 a 100% increased risk of non-fatal cardiovascular events,9 particularly recurrent stroke,9,10 and a 75% 
increased risk of early death.11 Observational data suggest that continuous positive airway pressure (CPAP), 
the first-line treatment for OSA, holds promise to improve stroke recovery and reduce stroke recurrence.9,12-14 
However, poor CPAP adherence has undermined pilot trials, limiting the ability to assess efficacy4,15,16 and 
leading multicenter stroke trials to exclude initially poorly adherent participants.17,18 Individualized and theory- 
based behavioral interventions to improve CPAP adherence have shown benefits in the general population,19-25 
though have not been rigorously evaluated among stroke patients. Given fundamental differences and worse 
CPAP adherence in stroke patients compared to general OSA patients, behavioral interventions to increase 
CPAP use must be adapted for and tested among stroke patients. 
 
Our single arm SCOUTS2 pilot study showed some success of a combination of 1) early CPAP technical 
support, 2) motivational enhancement therapy (MET) directed toward the patient, and 3) follow-up phone 
interviews to provide adherence feedback and enhance self-management skills, on CPAP use in post-stroke 
patients.26 To maximize adherence and develop a more generalizable protocol, additional work is needed to 
adapt and supplement these interventions for stroke patients, who often have cognitive, language, and 
physical dysfunction. The goal of this application is to adapt the three promising and scalable interventions of 
the SCOUTS2 pilot study26 for stroke patients with OSA identified in an IPR setting, and to supplement this 
with MET directed toward a CPAP partner and mobile health (mHealth). Using self-determination theory (SDT), 
we will adapt these intervention components using a human-centered design approach to create a package of 
interventions to improve CPAP use. Following adaptation, we will (in a separate, future, IRB application) 
rigorously test the effectiveness of this multicomponent intervention on CPAP adherence among stroke 
patients within a randomized controlled trial (RCT). 
 
Goals and objectives 
Aim 1a: To adapt and refine the existing SCOUTS2 adherence interventions (CPAP technical support, 
MET, and phone follow-up) for stroke patients with OSA. Disability related to stroke, including arm/hand, 
language, and cognitive dysfunction, affects stroke patients’ ability to engage in interventions used in the 
general population to increase CPAP use. We will adapt CPAP adherence interventions iteratively, with input 
from stroke patients treated with CPAP on IPR, to increase CPAP use. 
Aim 1b: To develop theory-driven, tailored mHealth messages to motivate stroke patients to use CPAP. 
Using SDT, we will develop and adapt a library of tailored messages designed to improve perceived autonomy, 
relatedness, and competence regarding CPAP use after stroke. Tailored text, e-mail or phone messages, 
delivered via a web-based application, will be refined after initial pretesting among stroke patients. 
Aim 1c: To implement MET to partners of stroke participants treated with CPAP. Using MET counseling 
sessions during IPR, we will train CPAP partners to deliver autonomy-based support to patients with stroke. 
Significance 
Aim 1a. Adaptation of existing intervention components 
The three existing behavioral interventions in the proposed study have been shown to result in significant 
improvements in CPAP adherence among the general, non-stroke population with OSA.20,24,25,27-29 Using a 
health behavior change framework, we plan to adapt the adherence interventions for stroke patients. The 
adaptations in content and delivery will optimize the interventions for the unique needs and barriers faced by 
stroke patients, giving the greatest chance for a potent adherence intervention. The intervention deliverables 
will be available for immediate application to clinical practice and for future studies testing the benefits of CPAP 

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on stroke-related outcomes. The lessons from the iterative approach in the proposed human-centered design 
may also be valuable in developing future stroke interventions in other fields outside of OSA treatment. 
Aim 1b. Development of theory-driven, tailored mHealth messages 
Interventions with mHealth feedback have been shown to be effective when adapted to stroke patients for 
other adherence outcomes,30,31 though have yet to be adapted for post-stroke CPAP adherence. We seek to 
adapt existing CPAP support messages used for OSA patients non-adherent to CPAP,32 in content, style and 
format to be consistent with SDT and be applicable and accessible to the stroke population. The adaption, 
implementation and refinement through pretesting of a mHealth library of tailored messages intended to 
motivate CPAP use after stroke will serve as a guide to researchers and clinical providers in this field and 
potentially in other areas of stroke research. 
 
Aim 1c. Implementation of MET to CPAP partners of study participants 
A thematic analysis of data from our pilot study suggests that collaborative CPAP partner support could serve 
as a facilitator for CPAP adherence,33 as noted in the general OSA population.34 The addition of MET sessions 
with CPAP partners with the goal of empowering the partner to provide sustained autonomy-based support to 
the stroke patient would provide much-needed evidence for a novel adherence intervention. 
 
 
Study design and methods 
Overview 
Stroke patients on Neurology and PM&R will be screened for eligibility and interested eligible patients will be 
consented. While on either of two IPR units at the University of Washington (UW) or Harborview Medical 
Center (HMC), consented participants will be tested for OSA, and then, within a single-arm study, exposed to a 
multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Throughout 
the intervention exposure, participants’ CPAP use will be monitored, and input regarding the intervention will 
be sought from the participants, CPAP partners (ideally bedpartners, but if not available, then those who can 
provide support to the patient), and the research team implementing the intervention (sleep technologist, 
research coordinator, sleep coach, nurses). Semi-structured interviews will take place to obtain formal 
feedback from participants at three time points during their 3-month intervention. Data will be reviewed in 
meetings with the study team and a patient advisory board, and adaptations will be devised and then 
implemented within the next batch of Aim 1 participants. Through this iterative process that includes input from 
important stakeholders, the behavioral intervention will be adapted for use among stroke patients. 
Participants and eligibility criteria 
60 adult patients recovering from acute stroke within the past 30 days will be recruited during inpatient acute or 
IPR (2 IPR units) stroke stays. 
Inclusion criteria include: 
1. Age 18 years or older 
2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within 
past 30 days 
3. Person providing consent (patient or legally authorized representative) able to be consented in English or 
Spanish. 
Exclusion criteria include: 
1. Unable to obtain informed consent from participant or surrogate in English or Spanish 
2. Incarcerated 
3. Known pregnancy 
4. Current mechanical ventilation, tracheostomy or supplemental oxygen use > 4L/min 
5. Current use of positive airway pressure or use within 14 days prior to stroke 
6. History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use 
7. Stroke related to tumors, vascular malformations or subarachnoid hemorrhage 

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8. Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any 
benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the 
planned portable sleep apnea study 
9. Anticipated inpatient rehabilitation length of stay < 3 nights 
10. Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team 
Recruitment and consent of study participants 
Patients: We will review medical records of the acute stroke and/or IPR patients to identify those who may be 
eligible to participate. We request a HIPAA waiver for this chart review. Patients will be approached in person. 
The study will be described by a study team member, which may be supplemented by an introductory video 
(appended). All questions will be answered. Before participation in any study related activity, written informed 
consent will be obtained from the participant or legally authorized representative (LAR). Assent will be used if 
appropriate for those who need an LAR. Written documentation of assent will not be collected. eConsent may 
be used. A copy of the informed consent instrument will be provided to each participant. 
 
CPAP partners: Partners will be selected by participants as the bedpartner or the person most likely to be able 
to provide support for CPAP use. The purpose of the study will be described to the CPAP partner, in person, 
by secure video, or by phone. All questions will be answered. Written informed consent will be obtained directly 
from the partner. eConsent may be used. Not all participants will identify a CPAP partner for participation. 
 
Identification of advisory board members and clinical team members 
The advisory board members may include previous participants in the study team’s research on CPAP for 
stroke patients. No advisory board member will be a current participant in one of the study team’s studies. 
CPAP partners of previous study participants may also be included in the advisory board. Advisory board 
members are not subjects of the proposed research. They will be used for consultation and feedback on study 
design and implementation issues. Similarly, clinical and research team members will be identified based on 
their contact with a research subject. They may be asked questions about the implementation of the study 
procedures but are not research subjects themselves. 
 
Baseline and rehabilitation discharge assessments 
After consent, health information including medical history, medications, stroke type (ischemic vs ICH) and 
severity, and stroke treatments will be obtained. Questionnaires and stroke evaluations will be assessed by a 
certified investigator, including baseline stroke severity (the NIH Stroke Scale, appended), functional disability 
(mRS-9Q, appended), pre-stroke symptoms of sleep apnea (the Berlin Questionnaire, appended), questions 
about CPAP beliefs (Apnea Beliefs Scale, appended), and questions about pre-stroke sleep duration and 
quality (see below). Near the day of inpatient rehabilitation discharge, study staff will repeat the the NIHSS. In 
cases of aphasia or cognitive deficits, the participants’ proxy, which can include the bedside nurse, may be 
asked to help complete the assessment. We anticipate the time to complete assessments will be between 10 
to 15 minutes. 
Sleep duration: 
During the month prior to the stroke, excluding naps, how many hours of actual sleep did you get at night (or 
day, if you work at night) on average? 
Sleep quality: 
During the month prior to your stroke, how would you rate your sleep quality overall? (Likert scale, with 1 = 
excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor). 
Screening for OSA 
A single-night portable home sleep apnea test (HSAT) using the Nox T3s sleep apnea test will be obtained in 
all participants idealy on night 1 after enrollment, assessing for the presence of OSA, defined as a respiratory 
event index (REI), the number of apneas and hypopneas per hour of recording, ≥ 5 with 3% desaturation 
criteria for hypopneas,35,36 and the absence of predominant central sleep apnea (CSA, absence defined as 
central apnea index < 50% of total REI). The Nox T3s components include the T3s device, a nasal pressure 
cannula, wrist-based oximeter unit with finger probe, and two respiratory inductance plethysmography (RIP) 

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belts for the chest and abdomen to assess respiratory effort, as recommended by the AASM.37 Participants 
who do not meet criteria for a diagnosis of OSA and those with predominant CSA will be excluded and the 
results will be given to the study participant and the IPR team caring for the participant. The study may be 
repeated if necessary to obtain the needed data. 
 
Nox T3s data will be uploaded for review by a scoring team at Elite Sleep Professionals, or similar organization 
of registered polysomnographic technologists. The sleep apnea tests will not be reviewed by a physician. 
Study participants who are eligible for the CPAP adherence intervention will not be told of the severity of OSA 
until completion of study participation so that any decision to adhere to CPAP is not influenced by OSA severity 
from a single-night HSAT, which typically underestimates the disease severity.38-40 Nox T3s reports will be 
provided to the participant and the clinical team at the time the participant exits participation in this study. 
Based upon prior studies in this population4-6 17 we anticipate that about 20% of the 60 participants with 
completed OSA tests may be excluded based on these criteria, yielding approximately 48 participants for the 
Aim 1 adherence program adaptation. 
 
Existing SCOUTS2 adherence intervention, implemented for participants 
Participants who meet criteria for a diagnosis of OSA will be set up with CPAP on the next available night after 
the HSAT by study staff led by the study’s sleep technologist, who will provide mask fitting and CPAP exposure 
during the daytime prior to the 1st night of CPAP use. The CPAP device (AirSenseTM 11 AutoSet, ResMed) 
includes an auto-titrator that can adjust the delivered pressure between 4 to 20 cm of water to eliminate 
obstructive events. Pressure settings may be narrowed. All Aim 1 participants may receive 3 basic supportive 
treatments to approximate the care provided after a sleep clinic or in-hospital diagnosis of OSA: 1) education 
on OSA and the importance of CPAP treatment for improved sleep and vascular health; 2) standard inpatient 
CPAP support from respiratory therapy and IPR nurses for mask placement and adjustments; and 3) outpatient 
access to a national durable medical equipment (DME) company, for issues that may arise with CPAP at 
home. Participants may also receive 3 behavioral adherence interventions: 
 
(i) 
CPAP technical support: Initial mask fitting will be completed by the study’s sleep technologist on the 
IPR unit rather than by respiratory therapists, if possible. The study’s sleep technologist will initially ensure 
adequate mask fit without air leak, trial different CPAP mask interfaces for patient comfort and provide 
education or adjustments to address adherence issues.41 A member of the SCOUTS3 team led by the study’s 
sleep technologist may then meet ideally daily with participants over the first three days of initiating CPAP to 
assess perception of treatment and symptom-related treatment response;42,43 complete a 7-item questionnaire 
of common adverse symptoms associated with CPAP (appended);44 make mask type/size or device 
adjustments, as needed; and provide training to participants and CPAP partners to improve skills involved with 
mask placement and device maintenance. For participants with non-acceptance of CPAP over the first night, a 
standardized desensitization program may be implemented by the sleep technologist. Persistent problems with 
CPAP use, mask fit, or high residual respiratory events may be discussed between the sleep technologist and 
Co-I Dr. Billings, a board-certified sleep medicine physician. 
(ii) 
MET with individualized verbal and written feedback: In-person MET sessions during IPR and 
telephone sessions after IPR discharge will also be completed by a sleep coach. The in-person MET sessions 
will occur typically within 3 days of starting CPAP and again after about 3 to 5 days if the participant remains 
on IPR. The 1st in-person MET session will focus on subjective assessment of CPAP use, barriers and 
facilitators of use, assessment of motivation and confidence for use, decisional balance and feedback. The 2nd 
MET session will focus on subjective appraisals of CPAP adherence, reinforcement of changes with treatment, 
and review of treatment goals. The post-discharge MET phone sessions will begin approximately two weeks 
after discharge, then monthly during the 3 months of CPAP therapy and will last approximately 30-60 minutes. 
Consistent with prior research in stroke patients on the dose of MET needed, the goal will be to deliver a total 
of 4 hours of MET counseling over the 3 months of CPAP therapy.45,46 In the spirit of MET, the participants will 
dictate the pace of the sessions. We may alter the frequency, duration, and content of the sessions based on 
participant feedback. 
 
For aphasic participants, the sleep coach will use published recommendations to adapt MET sessions for 
people with stroke-related aphasia, including strategies to enhance language comprehension and facilitate 

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expression 47-49 and patient-specific strategies recommended by the study participant’s speech-language 
pathologists on the IPR unit. Patients with more severe aphasia with complete incomprehension are not 
typically admitted to IPR. The MET for aphasic participants will include two face-to-face sessions during IPR, 
each lasting about 30 to 60 minutes, and one ~20-minute phone session with inclusion of the CPAP partner, 
when possible. Face-to-face sessions will incorporate MET components used in non-aphasic participants but 
will focus on information exchange through visual aids, exploring potential barriers to CPAP use through 
enhanced communication and goal setting.50 MET sessions may be bolstered by individualized written and 
visual feedback regarding the OSA testing, potential vascular consequences, and CPAP download data 
illustrating the effectiveness of treatment in reducing respiratory events. 
 
Fidelity for the MET sessions will be evaluated in multiple ways. Some MET sessions will be recorded, 
uploaded for processing, and reviewed via the cloud-based and HIPAA-compliant Lyssn platform, which 
supports training and quality assurance by providing automated transcription and fidelity feedback from a 
session recording. The recordings are processed through the system’s artificial intelligence analytics tool and 
automatically transcribed via speech-to-text transcription. The platform will produce reports of each session, 
including general and specific metrics for MET. The sessions will be evaluated through the Lyssn platform and 
feedback reports will be provided to the sleep coach. Consultants, Dr. Barbara McCann and Dr. Mark Aloia, 
may also review ~20% of the counseling sessions for non-aphasic participants utilizing a MET checklist to 
provide feedback to the sleep coach via quarterly virtual meetings.20 Co-I Dr. Bombardier, who has adapted 
motivational counseling to improve adherence to therapy in other populations,51 may review ~20% of the 
recordings of aphasic participants utilizing a modified MET checklist. 
 
(iii) 
Phone follow-up for adherence feedback and self-management skills: The research coordinator will call 
participants approximately monthly to encourage use and resolve problems with therapy.21 In an effort to 
improve CPAP tolerance and minimize side effects, the research coordinator will provide encouragement and 
basic education, review persistent outpatient CPAP-related issues with co-I Dr. Billings and refer participants 
toa durable medical equipment (DME) company when needed for device or mask adjustments. 
90-day end-of-study assessment 
After approximately 90 ± 14 days from enrollment, phone evaluations by study will be obtained by a certified 
investigator, including the mRS-9Q, questions about sleep duration and quality, and the Zarit Burden Interview. 
We anticipate the time to complete assessments will be between 10 to 15 minutes. 
 
 
AIM 1: SCOUTS3 Single-arm study— Research design and methods overview. 
Visit 1: (in-hospital and in-person during inpatient rehabilitation) 
• 
Stroke participants will be asked to provide contact information for themselves and their primary 
caregiver or family member. 
• 
Contact information will be obtained for a “CPAP partner,” either a bed partner or caregiver who can 
assist with CPAP use 
• 
A brief (~10 minutes) set of questionnaires and assessments will be obtained for baseline stroke 
severity and functional disability by a certified investigator. 
• 
Neck circumference will be measured by a study team investigator. 
• 
The medical record will be reviewed and key data extracted, including medical history, neuroimaging 
and any note for common implantable devices that can be affected by magnets (pacemakers and 
intracranial shunt). 
• 
Participants will be screened for any personal or bed-partner medical implants that can be 
affected by magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), 
neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps) or metallic 
implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption 
devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with 
implanted magnets, hearing implants, metallic splinters in the eye). If participant has any 
such medical implants or metallic implants/objects, a note will be made in the database to 

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refrain from using magnet-containing masks. 
 
 
Visit 2: (in-hospital and in-person during inpatient rehabilitation) 
• 
The participant will be set-up by a study team member with a single-night sleep test on night 1 after 
enrollment to assess for the presence of OSA using the Nox T3 or T3sTM portable home sleep apnea 
test monitor (includes the T3/T3s device, a nasal pressure cannula, wrist-based oximeter unit with 
finger probe, and two respiratory inductance plethysmography belts for the chest and abdomen). The 
Nox T3 may be repeated up to 2 times in the rare cases of failed recordings or self-reported poor sleep 
if the participant is willing to repeat the study. 
Visit 3: (in-hospital and in-person during inpatient rehabilitation) 
• 
Participants will be informed of their eligibility in the study approximately 1 day after the sleep apnea 
study (if the respiratory event index or REI, the number of apneas and hypopneas per hour of 
recording, ≥ 5 with 3% desaturation criteria for hypopneas, and the absence of predominant central 
sleep apnea, defined as central apnea index < 50% of total REI). 
• 
Study participants will be informed the day after the testing but will not be told of the severity of OSA 
until completion of study participation so that any decision to adhere to CPAP is not influenced by OSA 
severity. 
Visit 4: (in-hospital and in-person during inpatient rehabilitation) 
• 
Participants with a diagnosis of OSA will be set up with CPAP on the next available night after the sleep 
apnea test by the study’s sleep team led by the study’s sleep technologist, who will provide mask fitting 
and CPAP exposure during the daytime prior to the 1st night of CPAP use. 
• 
Magnetic masks will not be used in participants with implantable devices or metallic objects affected by 
magnets. 
• 
The CPAP device (AirSenseTM 11 AutoSet, ResMed) includes an auto-titrator that adjusts the delivered 
pressure between 4 to 20 cm of water to eliminate obstructive events. 
 
Visits 5-7 (in-hospital and in-person during inpatient rehabilitation) 
• 
Study’s sleep team will meet daily with participants over the first three days of initiating CPAP to assess 
perception of treatment and symptom-related treatment response; complete a 7-item questionnaire of 
common adverse symptoms associated with CPAP; make mask type/size or device adjustments, as 
needed; and provide training to participants and CPAP partners to improve skills involved with mask 
placement and device maintenance. 
 
Visit 8 (in-hospital and in-person during inpatient rehabilitation) 
• 
Interview with participants and, if available, CPAP partners after 3 days to evaluate impressions of 
CPAP technical support 
• 
Interviews will last approximately 30 minutes 
Visit 9 (in-hospital and in-person during inpatient rehabilitation) 
• 
An in-person Motivational Enhancement Therapy (MET) session will occur by a trained sleep coach 
within the first the first week of starting CPAP and again within a week if the participant remains on IPR. 
Initial session will last approximately 60 minutes for non-aphasic participants. 
• 
For aphasic participants, the sleep coach will use published recommendations to adapt MET sessions 
for people with stroke-related aphasia, including strategies to enhance language comprehension and 
facilitate expression and patient-specific strategies recommended by the study participant’s speech- 
language pathologists on the IPR unit. These sessions will focus on information exchange through 
visual aids, exploring potential barriers to CPAP use through enhanced communication and goal setting 
and will last 30-60 minutes 
• 
An in-person or phone MET session will also be conducted with a CPAP partner, when available. With 
participant permission, MET sessions for CPAP partners will focuse on the OSA diagnosis, standard 
therapy for OSA and ways the CPAP partner can provide support for the participant 

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Visit 10 (in-hospital and in-person during inpatient rehabilitation) 
• 
A second in-person Motivational Enhancement Therapy (MET) session will occur within a week if the 
participant remains on inpatient rehabilitation. 
Visit 11 (in-hospital and in-person during inpatient rehabilitation) 
• 
The research coordinator will meet with participants to assist in registering for the mobile health 
(mHealth) ResMed myAir app, demonstrate use of the app, and provide increased support to 
participants if needed, including those with deficits related to dexterity, aphasia and cognition. 
Increased efforts will be made with aphasic participants or those with other cognitive or dexterity 
deficits, including frequent coaching during IPR, utilizing patient-specific strategies recommended by 
the IPR unit’s speech-language pathologists and working with caregivers when possible. 
• 
Participants limited by dexterity issues will be trained to use a stylus. Screen zoom features will be 
implemented if the participant has difficulty seeing due to presbyopia. Tablets or internet card-enabled 
devices will be provided to those without access to smartphone, tablet or home internet service. 
Visit 12 (in-hospital during inpatient rehabilitation) 
• 
At the end of inpatient rehabilitation, a brief (~10 minutes) set of questionnaires and assessments will 
be repeated for baseline stroke severity and functional disability by a certified investigator. 
• 
Interview with participants and, if available, CPAP partners will be conducted to evaluate impressions of 
the inpatient MET sessions and mHealth interventions 
Visit 13-14 (by phone to participant’s home or other facility after discharge from inpatient rehabilitation) 
• 
A post-discharge MET phone sessions will occur approximately two weeks after discharge from the 
inpatient rehabilitation unit and last approximately 30-60 minutes. 
• 
A repeat and final MET phone session will occur approximately 1 months after the prior one and will 
last approximately 30-60 minutes 
Visit 15-16 (by phone to participant’s home or other facility after discharge from inpatient rehabilitation) 
• 
The research coordinator will call participants approximately monthly after discharge from the inpatient 
rehabilitation unit (on 2 occasions over the 3-month study treatment period) to encourage use and 
resolve problems with therapy. 
Visit 17 (by phone to participant’s home or other facility after discharge from inpatient rehabilitation) 
• 
After approximately 90 ± 14 days from enrollment, a certified investigator will repeat questionnaires and 
assessments (~10 minutes) for baseline stroke severity and functional disability. 
• 
At the end of the 3-month treatment period, a repeat interview with participants and, if available, CPAP 
partners will be conducted to evaluate impressions of the outpatient MET sessions and mHealth 
interventions 
 
Between visits at 11 and 16, participants will continue to receive messages through the ResMed myAir app (11 
messages over the first 60 days of use that are time-based and designed to provide education to make CPAP 
more comfortable and build confidence). These messages are presented by email, but texting can be selected 
by the participant. Supplemental to myAir, the research team will also send CPAP support messages using 
simple language (8th grade level) which will be tailored to the participant’s current CPAP use. Message delivery 
will be implemented through a web-based program designed to deliver CPAP care management, via the 
participant’s preferred mode of delivery (text, email, or automated phone messages). 
 
MET sessions recordings will be uploaded into the HIPAA compliant Lyssn platform for evaluation. 
If any component of the adherence intervention is not delivered, it will not be reported as a protocol 
violation/deviation as this is an expected part of this project which is designed to adapt the intervention 
protocol. 
Adaptation and refinement 

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Our adaptation approach will be guided by the simple and iterative Discover, Design and Build, and Test 
(DDBT) framework for psychosocial and health behavior change intervention development and adaptation 
stemming from a human-centered design perspective.52 The DDBT approach aims to maintain the core 
components of interventions while improving usability for specific populations (here, stroke patients with OSA) 
and implementation outcomes in specific settings (here, acute IPR and in the home).53-59 (i) The Discovery 
phase seeks to identify facilitators and barriers of contextual usability among stakeholders. This phase will 
initially involve interviews of participants, their CPAP partners, when available, and intervention staff (sleep 
technologist, sleep coach, and research coordinator) to explore CPAP barriers and facilitators through 
structured and open-ended feedback opportunities. Interviews with participants and CPAP partners lasting 
approximately 30 minutes will occur typically after the first 3 days of CPAP technical support, at the end of IPR 
to evaluate the MET and mHealth interventions and at the end of the 3-month treatment period to assess 
outpatient and prior IPR treatments. Interviews with the intervention staff, occurring quarterly from the 
beginning to the end of aim 1 and lasting approximately 20 minutes, will focus on feedback about the content, 
process and feasibility of each intervention.60 The study team will analyze after about 6 months of recruitment 
the participant interviews and adherence patterns after completion of an estimated 15 of the 3-day interviews, 
13 of the end-of-IPR interviews and 8 of the 3-month interviews. Analysis of participant, CPAP partner and staff 
interviews along with adherence and engagement data will feed Discovery. (ii) The Design and Build phase 
uses the Discovery information to iteratively refine the intervention and implement strategies to address the 
unique barriers faced by stroke IPR patients as they work to engage with the intervention components to 
successfully and consistently use CPAP. Refinements in Aim 1 will involve iterative and collaborative content 
and delivery adaptation by the study team based on the Discovery data above. The study team will present 
adaptation proposals to a stroke patient advisory board. This may be repeated as needed. After approximately 
6 months of recruitment, researchers will review interview feedback with the patient advisory board and 
present proposed adaptations to the interventions. The patient advisory board will review these proposals and 
make recommendations for adapting the behavioral interventions. (iii) The Test phase evaluates the 
intervention’s user experience, satisfaction, and implementation outcomes. The adapted intervention will be 
tested on the next 12 participants over an estimated 4 months. The iterative DDBT cycle will be repeated, with 
results being presented again to the patient advisory board with additional adaptation feedback, as needed. 
We will conduct ‘think-aloud’ cognitive interviews with the next approximately 5 participants while they interact 
with the intervention components to elicit organic reactions to the intervention and reveal any final needed 
adaptations.61,62 
 
mHealth component of the intervention 
In the proposed study, mHealth support will include two key features: implementation of the ResMed myAir app 
and implementation of tailored and targeted messages for participants. 
myAir: The myAir app, free of charge to patients with the AirSense 11 CPAP device, allows self-tracking of 
adherence and participation in decision making and problem solving63,64 through three integrated services: (1) 
self-tracking of CPAP use: participant’s data from the prior night’s use including hours used, mask seal, 
residual AHI, mask on/off events, and a summary score based on these metrics (0-100 scale). (2) Coaching 
and reinforcement messages: 11 messages over the first 60 days of use that are time-based and designed to 
provide education to make CPAP more comfortable and build confidence. Additionally, myAir provides event- 
based messages including the following: praise message (based on hourly usage), alert messages (based on 
low use), leak alerts and suggestions (based on mask leaks), AHI alerts (based on high residual AHI), no data 
alerts (for no data during 5 of 7 days), and badges (awards for reaching usage milestones). These messages 
are presented by email, but texting additionally can be selected by the participant. (3) Educational tools: the 
myAir sleep library provides instructions and videos to assist with therapy. Participants will be encouraged to 
use the app during IPR. Research coordinators will assist in registering for myAir, demonstrate use of the app, 
and allow participants to practice accessing data through the app and messages through their email. Increased 
efforts will be made with aphasic participants or those with other cognitive or dexterity deficits, including 
frequent coaching during IPR, utilizing patient-specific strategies recommended by the IPR unit’s speech- 
language pathologists and working with caregivers when possible. Participants limited by dexterity issues may 
be trained to use a stylus. Tablets or internet card-enabled devices will be loaned to those without access to 
smartphone, tablet or home internet service. 

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Tailored messages: Supplemental to myAir, we will again use DDBT to adapt, implement, and refine through 
pretesting the use of mHealth messages designed to motivate CPAP use specifically in stroke patients. A 
library of CPAP support messages using simple language will be created and/or adapted from a prior 
intervention,32 to be consistent with SDT, targeted to stroke patients, and tailored to current CPAP use. 
Message delivery will be implemented through a web-based program to deliver CPAP care management, via 
the participant’s preferred mode of delivery (text, email, or automated phone messages). CPAP data will be 
provided by ResMed and integrated within REDCap. Message logic will be programmed into REDCap. 
REDCap will be integrated with the Mosio platform which will be used to send the text messages. Two-way 
texting will also be possible through Mosio’s platform for communication between study staff and participants. 
Mosio is HIPAA-compliant and compliant with FDA 21 CFR PART 11. 
Implementation of MET to CPAP partners of participants with stroke. We plan to implement MET for 
CPAP partners. Partners will be selected by participants as the bedpartner or the person most likely to be able 
to provide support for CPAP use. MET sessions for CPAP partners will take place in-person during IPR visits, 
or by phone or secure video. The initial session will focus on background information, including (with 
participant permission) the OSA diagnosis, standard therapy for OSA and ways the CPAP partner can provide 
autonomy support for the participant.50 Not all participants will identify a CPAP partner. Partners will be taught 
to deliver autonomy support to the stroke participant to help support his/her CPAP use. 
 
Data collection 
Study personnel will enter data into a UW REDCap database. REDCap is a HIPAA-compliant, secure, easy to 
use online data capture platform. The REDCap platform can support processes that are 21 CFR part 11 
compliant. Data integrity and completeness are monitored by REDCap and enhanced by flags for missing data, 
range checks, and frequent quality control reports. Paper documents will be kept in a locked office. 
 
Human subjects 
Potential Risks to participants 
The Nox T3s portable sleep apnea test used to identify those with qualifying sleep apnea is FDA cleared 
(K082113) for evaluation of adults for sleep-disordered breathing and is intended for hospital or home use. The 
components include a nasal cannula, thoracic and abdominal Respiratory Inductance Plethysmograph (RIP) 
belts, and wrist oximeter unit with finger probe. We will upload sleep apnea test data from the Nox T3s device 
Elite Sleep Professionals, or similar company, to provide rapid scoring and reporting of study results along with 
data storage during and after the trial. Study data will be shared with the scorer via a HIPAA-compliant means. 
The studies will contain embedded study date, but otherwise should not contain PHI. Potential risks to 
participants include the loss of privacy and confidentiality from data gathered from the Nox T3s, CPAP device, 
and the recordings of the MET interviews. Data from the CPAP devices automatically upload via modem to 
ResMed AirViewTM cloud application, a secure CPAP adherence monitoring program that is typically used by 
home medical equipment companies and sleep medicine clinics to ensure patients meet insurance company 
requirements for adherence. ResMed’s AirView will also be used to track CPAP use. ResMed’s privacy policy 
can be found here: https://www.resmed.com/en-us/privacy/ The MET interviews are also recorded and 
analyzed by Lyssn, a HIPAA-compliant, cloud-based software platform that supports training and quality 
assurance through automated transcription of counseling session recordings. Other risks of study participation 
include stress or anxiety related to completing health questionnaires. Information from surveys or the sleep 
apnea test (in instances of predominant central sleep apnea) may be shared with IPR care providers to assist 
in treatment. 
The use of CPAP for treatment of OSA should be exempt from the requirements of 21 CFR Part 812 because 
this represents a medically cleared device (ResMed AirSense 11 AutoSet: K203126), used for its labeled 
indication (i.e., treatment of OSA). The UW Institutional Review Board (IRB) has assigned a no more than 
minimal risk status in similar studies.26,65,66 CPAP is a safe treatment. The most common side effects of CPAP 
include mask-related discomfort; dry eyes, nose, mouth and/or throat; nasal congestion; stomach bloating; and 
difficulty falling or staying asleep. These are all non-serious. Skin irritation related to the mask interface, or 
rarely skin allergy can occur. We will minimize these risks by having a variety of mask and nasal pillow 
interfaces, and offering multiple options. Respiratory therapists and sleep technicians will assist with mask fit 
and troubleshoot any discomfort during the IPR hospitalization. For all participants, we will make use of 

11 
 
respiratory therapy expertise during IPR and provide information for DME-support after IPR discharge to make 
CPAP as comfortable as possible, which would be covered by the study. For persistent issues related to 
CPAP, the study team may ask the participant if he/she would like a referral to the local sleep medicine clinic, 
that would not be covered by the study. 
 
Protection Against Risk 
Patients will be excluded from the study after enrollment if they are found to have central sleep apnea (≥ 50% 
of apneas related to central events) or no evidence of OSA (respiratory event index < 5 per hour) on the Nox 
T3s sleep recording. In such case, the results of the sleep apnea testing will be given to the participant and the 
IPR clinical team caring for the patient. Either a sleep technologist or respiratory therapist, depending on 
randomization assignment, will be involved in mask fitting to assure appropriate size selection. For all 
participants, the respiratory therapists or sleep tech will troubleshoot any CPAP issues during ideally each 
night of inpatient use. Participants will also be offered a variety of masks/interfaces to facilitate comfort. Heated 
humidification will be used to reduce mucosal dryness and maximize adherence. The consent form provides 
information about withdrawal of study participants for pregnancy and the need to discuss this topic, should it 
arise, with study staff and the participant’s physician. This should be rare given our stroke population. 
Participants will be cautioned not to drive when sleepy, though sleepiness is not a prominent feature of post- 
stroke OSA.67-69 
Regarding loss of privacy or confidentiality from data gathered from the Nox T3s sleep apnea test, CPAP use 
or MET interviews, all participant health information and personal identifiable information is kept confidential on 
ResMed AirView, ResMed myAir and Lyssn cloud-based applications. Also, the privacy policy from ResMed, 
and Lyssn will be provided to participants at the time of enrollment. The informed consent document will outline 
the use of these applications including the need to share identifiers with ResMed as part of this use - a 
procedure often done as part of routine medical care related to CPAP. Regarding risks of the questionnaires or 
MET counseling sessions, participants will be given the option to stop answering questionnaires or counseling 
or to take a break if they become physically tired or emotionally upset. No particularly sensitive topics are 
planned for discussion. Participants will be assured that they are not required to answer a question if a 
particular question makes them uncomfortable and can also withdraw their study participation at any time. 
The data collection process or MET session will be postponed and rescheduled at another time if needed and 
if agreeable to the participant. Our study staff will undergo strict training in the proper way to conduct interviews 
with personal health information, including HIPAA and Good Clinical Practice (GCP) training. We protect 
Protected Health Information (PHI) with all of our efforts. Study participants’ identification numbers will be used 
on forms rather than names. 
 
Vulnerable Subjects 
No prisoners, children, or pregnant women will be enrolled. Pregnancy is an exclusion criterion because of 
potential safety concerns for the fetus and mother related to untreated OSA. Women of child-bearing potential 
will be included. Participants who become pregnant will be withdrawn from the study. This should be 
uncommon given the stroke population. Pregnancy testing is considered part of routine care for stroke patients. 
 
Potential Benefits 
Potential direct benefits to research study participants include sleep apnea testing using a portable device, 
education regarding OSA after stroke, and CPAP therapy for all those who meet the study’s OSA treatment 
criteria. Both the screening sleep apnea study and the initiation of CPAP are rarely performed in the inpatient 
stroke setting due to logistic challenges and clinical equipoise related to the potential benefits of early CPAP 
treatment. Benefits to the intervention may include improved adherence to CPAP therapy, improved stroke 
recovery or secondary stroke prevention and better overall health outcomes. In regards to indirect benefits, the 
project has the potential to generate important new and much-needed information about improving adherence 
to CPAP therapy and the treatment of post-stroke OSA. The no more than minimal risks associated with this 
study are reasonable considering the significant potential direct and indirect benefits. 
Enrolled stroke participants will be compensated for their time with $25 for completion of the outcome 
assessment at 3 months. 

12 
 
AE monitoring and reporting 
Given the no more than minimal risk nature of the study, Dr. Khot will be responsible for monitoring the safety 
of participants. Given the risks, only serious adverse events that are definitely, possibly, or have a reasonable 
possibility of being related to a study procedure will be reported to the IRB. Standard definitions of serious 
adverse events, relatedness, and seriousness will be used. Standard reporting scheduled will be applied. 
Statistical analysis 
 
The primary endpoint is the themes related to acceptability, feasibility, and appropriateness of the 
behavioral adherence intervention based upon participant and CPAP partner feedback during the 
semi-structured interviews. The secondary endpoint is 3-month average nightly CPAP usage. 
 
Demographic and stroke- or sleep-related factors associated with mean CPAP use will be assessed 
using t-tests for dichotomous variables and linear regression for continuous variables. Additional post- 
hoc analysis of race/ethnicity may be completed. 

13 
 
Introductory Pamphlet (to be edited) 

14 
 
NIH Stroke Scale 
 
 
NIH Stroke Scale Item 
Function 
Scores 
Score 
Alert 
0 
1a. Level of Consciousness 
Drowsy 
1 
(Alert, Drowsy, etc.) 
Stuporous (requires repeated stimuli) 
2 
Comatose (reflex responses only) 
3 
1b. LOC Questions 
(Ask month, age) 
Both correct 
One Correct 
Both Incorrect, unable to answer· 
0 
1 
2' 
1c. LOC Commands 
(Open, close eyes, make fist, let go} 
Obeys both correctly 
Obeys one correctly 
Both Incorrect, unable to perform• 
0 
1 
2' 
2. Best Gaze 
(Eyes open-patient follows examiner's 
finaer or racel 
Normal 
0 
Partial gaze palsy 
(for coma see 
1 
Forced deviation 
Note 2 below) 
2 
3. Visual 
(Introduce visual stimulus hreat to 
patient's visual field quadrants) 
No loss 
0 
Partial hemianopia 
(for coma see 
1 
Complete hemianopia 
Note 3 below) 
2 
Bilateral hemianopia 
3 
4. Facial Palsy 
(Show teeth, raise eyebrows and 
squeeze eyes shut) 
Normal 
0 
Minor asymmetry 
1 
Partial (lower face paralysis) 
2 
Comolete• 
3• 
5a. Motor Arm-Left 
(Elevate extremity 90 degrees When sitting and score 
drift/movement} 
No drift 
0 
Drift 
1 
Some effort against gravity 
2 
No effort against gravity 
3 
No movement" 
4" 
5b. Motor Leg-Left 
(Elevate extremity 30 degrees When lying down and 
score drift/movement) 
No drift 
0 
Drift 
1 
Some effort against gravity 
2 
No effort against gravity 
3 
No movement• 
4' 
6a. Motor Arm-Right 
(Elevate extremity 90 degrees When sitting and score 
drift/movement) 
No drift 
0 
Drift 
1 
Some effort against gravity 
2 
No effort against gravity 
3 
No movement' 
4' 
6b. Motor Leg-Right 
(Elevate extremity 30 degrees When lying down and 
score drift/movement) 
No drift 
0 
Drift 
1 
Some effort against gravity 
2 
No effort against gravity 
3 
No movement· 
4• 
7. limb Ataxia 
(Finger-Nose, heel down shin) 
Absent' 
Present in upper or lower 
Present in both 
o· 
1 
2 
8. Sensory 
(Pin prick to face, arm, trunk, and leg 
comoare side to sidel 
Normal 
0 
Partial Loss 
1 
Dense Loss• 
2' 
9. Best Language 
(Name items, describe picture and 
read sentences) 
No aphasia 
0 
Mild-moderate aphasia 
1 
Severe aphasia 
(see Intubated 
2 
Mute• 
and Alert notes 
3· 
10. Dysarthria 
(Evaluate speech darity by patient 
repeatina listed words) 
Normal articulation 
if appropnate) 
0 
Mild-moderate slurring 
1 
Severe. nearly unintelliaible or worse· 
2· 
11. Extinction and Inattention 
(Use information from prior testing to identify 
nealect or double simultaneous stimuli testinal 
No neglect 
0 
Partial neglect 
1 
Profound Neolecr 
2· 
NIH Stroke Scale Total 
• assign this score 1f patient comatose or unresponsive 
Note 2: perform oculocephalic testing to determine score if comatose, absent oculocephalic reflex leads to score of 2 
Note 3: determine via visual threat if comatose, no response leads to score of 3 
Intubated and Alert: for item 9, make best guess and score; for item 10, untestable so score O 

15 
 
MRS-9Q 
 
Question 1: Do you have any symptoms that are bothering you? YES | NO 
Question 2: Are you able to do the same work as before? YES | NO 
Question 3: Are you able to keep up with your hobbies? YES | NO 
Question 4: Have you maintained your ties to friends and family? YES | NO 
Question 5: Do you need help making a simple meal, doing household chores, or balancing a checkbook? YES 
| NO 
 
Question 6: Do you need help with shopping or traveling close to home? YES | NO 
Question 7: Do you need another person to help you walk? YES | NO 
Question 8: Do you need help with eating, going to the toilet, or bathing? YES | NO 
Question 9: Do you stay in bed most of the day and need constant nursing care? YES | NO 

16 
 
Pre-stroke Berlin (baseline only) – 10 items 
 
 
Read to participant: “Please answer the following set of questions as you would have 
BEFORE your recent stroke.” 
1. Do you snore? 
0 = No (Go to 6.2) 
1 = Yes 
80 = Don’t know (Go to 6.2) 
1a. Would you say your snoring is: 
1 = Slightly louder than breathing 
2 = As loud as talking 
3 = Louder than talking 
4 = Very loud; can be heard in adjacent room 
80 = Don’t know 
 
1b. How often do you snore? 
1 = Nearly every day 
2 = 3-4 nights per week 
3 = 1-2 nights per week 
4 = 1-2 nights per month 
5 = Never/nearly never 
80 = Don’t know 
1c. Has your snoring ever bothered other people? 
 
0 = No 
1 = Yes 
80 = Don’t know 
2. Has anyone noticed that you quit breathing during your sleep? 
0 = No (Go to 6.3) 
1 = Yes 
80 = Don’t know (Go to 6.3) 
2a. How often would you say you quit breathing during your sleep? 
1 = Nearly every day 
2 = 3-4 times a week 
3 = 1-2 times a week 
4 = 1-2 times a month 
5 = Never/nearly never 
80 = Don’t know 
3. How often do you feel tired or fatigued after your sleep? 
1 = Nearly every day 
2 = 3-4 times a week 
3 = 1-2 times a week 
4 = 1-2 times a month 

17 
 
5 = Never/nearly never 
80 = Don’t know 
 
4. During your wake time, how often do you feel tired, fatigued, or not up to par? 
1 = Nearly every day 
2 = 3-4 times a week 
3 = 1-2 times a week 
4 = 1-2 times a month 
5 = Never/nearly never 
80 = Don’t know 
5. Have you ever nodded off or fallen asleep while driving a vehicle? 
0 = No (Go to 6.6) 
1 = Yes 
80 = Don’t know (Go to 6.6) 
 
5a. How often would you say you nod off or fall asleep while driving a vehicle? 
1 = Nearly every day 
2 = 3-4 times a week 
3 = 1-2 times a week 
4 = 1-2 times a month 
5 = Never/nearly never 
80 = Don’t know 
6. What is your height? 
 
feet  
inches 
 
7. What is your weight? 
 
lbs 
8. Do you have high blood pressure? 
RESPONSE OPTIONS: yes, no, don’t know 

18 
 
Motivation to Use CPAP Scale (baseline only) – 9 items - visit 8 (Day 5-7 and after 3-day ST visits) 
 
Now I’m going to ask you 9 questions about what motivates you to use CPAP. 
 
1. I use the CPAP treatment because it 
makes me feel good. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
2. I use the CPAP treatment because I 
want to avoid having apneas. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
3. I use the CPAP treatment because I 
want to feel more alert. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
4. I use the CPAP treatment because it 
feels important to use the CPAP. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
5. I use the CPAP treatment because my 
health is important to me. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
6. I use the CPAP treatment because it 
feels good to use CPAP. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
7. I use the CPAP treatment because other 
people say I have to. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
8. I use the CPAP treatment because the 
personnel say I have to. 
Strongly 
agree 5 
Agree 
4 
Undecided 
3 
Disagree 
2 
Strongly 
disagree 1 
9. I use the CPAP treatment because I 
have to. 
Strongly 
agree 5 
Agree 4 Undecided 3 Disagree 2 Strongly 
disagree 1 

19 
 
 
 

20 
 
Prestroke sleep duration & Quality (baseline in reference to pre-stroke state) 
Sleep duration: 
During the month prior to the stroke, excluding naps, how many hours of actual sleep did you get at 
night (or day, if you work at night) on average? 
RESPONSE OPTIONS: < 6 hours per night, 6-8 hours per night, > 8 hours per night 
 
Sleep quality: 
During the month prior to your stroke, how would you rate your sleep quality overall? 
RESPONSE OPTIONS: 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor 

21 
 
Prestroke sleep duration & Quality (90 day) 
Sleep duration: 
During the past month, excluding naps, how many hours of actual sleep did you get at night (or day, if 
you work at night) on average? 
RESPONSE OPTIONS: < 6 hours per night, 6-8 hours per night, > 8 hours per night 
 
Sleep quality: 
During the past month, how would you rate your sleep quality overall? 
RESPONSE OPTIONS: 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor 

22 
 
After Nox T3 sleep apnea test 
 
 
Was the T3 qualifying for CPAP treatment (REI ≥5 and CAI was <50% of REI)? 
RESPONSE OPTIONS: yes, no, sufficient data not obtained 
 
If yes, 
Did the participant try CPAP for at least one night? 
RESPONSE OPTIONS: yes, no 
 
Participant phone number: 
Participant email: 
Participant address: 
Did the participant identify a CPAP partner? 
RESPONSE OPTIONS: yes, no 
If yes, 
CPAP partner name 
CPAP partner phone number 

23 
 
7 adverse symptoms of CPAP (after night 1, night 2 and night 3 of using CPAP) 
 
 
“Did you have problems with CPAP last night?” 
 No 
 Yes 
“We would like you to answer yes or no to some side effects of CPAP that people may experience.” 
 
List of 7 adverse events or problems associated with CPAP use 
Patient receives a score of one point for the presence of any complaints within each category, producing a total 
possible side effect score of seven points. 
 
 
Mouth dryness 
Nasal symptoms 
Eye problems 
Claustrophobia 
Noise problems 
Facial soreness or skin irritation from the mask 
Mask fit or leak problems (i.e. trouble keeping mask in place, air leaks or difficulty putting the 
mask on) 
 
“Some other side effects that people may experience include: dry nose or throat, headache, sore throat, jaw 
pain, waking up frequently, stomach upset, or increased saliva. Have you had any of these side effects?” 
 

24 
 
Asked of CPAP Partner 
Short-form 7-item Zarit Burden Interview (discharge, 90 day) measured on a 5-point Likert 
scale from 0 (never) to 4 (nearly always) 
 
 
INSTRUCTIONS: The following is a list of statements, which reflect how people sometimes feel when taking 
care of another person. After each statement, indicate how often you feel that way; never, rarely, sometimes, 
quite frequently, or nearly always. There are no right or wrong answers. 
 
1. Do you feel you do not have enough time for yourself? 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
2. Do you feel stressed between caring and meeting other responsibilities? 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
3. Do you feel your relative affects your relationship with others in a negative way 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
4. Do you feel strained when are around your relative? 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
5. Do you feel your health has suffered because of your involvement with your relative? 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
 
 
6. Do you feel you have lost control of your life since your relative’s illness? 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
7. Overall, how burdened do you feel in caring for your relative? 

25 
 
RESPONES OPTIONS: 0: NEVER 1: RARELY 2: SOMETIMES 3: QUITE FREQUENTLY 4: 
NEARLY ALWAYS 
 
 
 
 
 

26 
 
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