A Pilot Study to Determine the Feasibility of a Couples' Oriented Intervention to Promote CPAP Adherence Among African American Patients With Obstructive Sleep Apnea
Phase: NA
Conditions: Sleep Apnea
Sponsor: MetroHealth Medical Center

 
 
 
 
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PROTOCOL TITLE: 
A PILOT STUDY TO DETERMINE THE FEASIBILITY OF A COUPLES’ ORIENTED 
INTERVENTION TO PROMOTE CPAP ADHERENCE AMONG AFRICAN AMERICAN 
PATIENTS WITH OBSTRUCTIVE SLEEP APNEA 
 
PRINCIPAL INVESTIGATOR: 
J. Daryl Thornton, MD, MPH 
Center for Reducing Health Disparities 
Department of Internal Medicine 
216-778-3732 
dthornton@metrohealth.org 
 
VERSION NUMBER/DATE: 
Version 5.0 
July 22, 2022 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1.0 
3/23/2022 
Initial Protocol 
No 
2.0 
4/28/2022 
Revision of Study Methodology and Consent Yes 
3.0 
5/3/2022 
Revision of Study Methodology 
No 
4.0 
5/6/2022 
Revision of Study Methodology 
No 
5.0 
7/22/22 
Revision of Study Methodology and Consent Yes 
 
 
 
 
 

 
 
 
 
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Table of Contents 
1.0 
Study Summary .............................................................................................................. 3 
2.0 
Background and Objectives ............................................................................................ 4 
3.0 
Background .................................................................................................................... 5 
4.0 
Study Endpoints ............................................................................................................. 7 
5.0 
Study Intervention/Investigational Agent ......................................................................... 7 
6.0 
Procedures Involved ....................................................................................................... 9 
7.0 
Data and Specimen Banking .........................................................................................12 
8.0 
Sharing of Results with Subjects ...................................................................................12 
9.0 
Study Timelines .............................................................................................................12 
10.0 
Inclusion and Exclusion Criteria .....................................................................................12 
11.0 
Vulnerable Populations ..................................................................................................13 
12.0 
Local Number of Subjects..............................................................................................13 
13.0 
Recruitment Methods ....................................................................................................13 
14.0 
Withdrawal of Subjects ..................................................................................................13 
15.0 
Risks to Subjects ...........................................................................................................13 
16.0 
Potential Benefits to Subjects ........................................................................................14 
17.0 
Data Management and Confidentiality ...........................................................................14 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects ...................................15 
19.0 
Provisions to Protect the Privacy Interests of Subjects ..................................................15 
20.0 
Compensation for Research-Related Injury ...................................................................16 
21.0 
Economic Burden to Subjects ........................................................................................16 
22.0 
Consent Process ...........................................................................................................16 
23.0 
Process to Document Consent in Writing ......................................................................16 
24.0 
Setting ...........................................................................................................................16 
25.0 
Resources Available ......................................................................................................16 
 
 
 

 
 
 
 
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1.0 
Study Summary 
 
Study Title 
A PILOT STUDY TO DETERMINE THE FEASIBILITY OF A 
COUPLES’ ORIENTED INTERVENTION TO PROMOTE 
CPAP ADHERENCE AMONG AFRICAN AMERICAN 
PATIENTS WITH OBSTRUCTIVE SLEEP APNEA 
Study Design 
Randomized Controlled Trial 
Primary Objective 
Mean CPAP adherence at 90 days 
Secondary 
Objective(s) 
Mean CPAP adherence at 30 days 
Change in mean CPAP adherence at 90 days (compared to 
baseline) 
Self-efficacy to use CPAP 
Patient and bed partner quality of life 
Patient and bed partner quality of sleep 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Peer motivators 
Behavioral couple therapy 
Telemonitoring and feedback 
IND/IDE #  
N/A 
Study Population 
African American patients with OSA and bed partner 
Sample Size 
20 patients and 20 bed partners 
Study Duration for 
individual 
participants 
90 days 
Study Specific 
Abbreviations/ 
Definitions  
OSA 
 
Obstructive Sleep Apnea 
CPAP   
Continuous Positive Airway Pressure 
 
 

 
 
 
 
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2.0 
Background and Objectives 
Obstructive sleep apnea (OSA), which affects 26% of adults over age 30 in the US1 and over 
900 million people worldwide2, is a disorder of sleep that results from intermittent complete or 
partial airway collapse and leads to episodes of apnea, hypopnea, and arousal from sleep.3,4  
Without treatment, OSA is associated with both immediate and long term adverse health 
outcomes, including motor vehicle accidents, hypertension,5 and coronary artery disease.6 
African Americans are more likely to develop OSA and its complications despite presenting with 
similar symptoms.7–9 Continuous positive airway pressure (CPAP) is efficacious in treating 
moderate to severe OSA10–12 and in preventing many of its complications. However, CPAP 
adherence is low among African Americans. 
 
In our prior work, we found that untreated OSA can also adversely affect the sleep and daytime 
functioning of bed partners by preventing them from having continuous, restful sleep.13,14 
Partners’ sleep loss often results in frustration, exhaustion, interference with work, and a 
strained relationship. In contrast, OSA treatment improves bed partner sleep quality and may 
improve intimate relationships.15 Perceived partner support is associated with more CPAP 
use.14 Few studies, however, have examined the efficacy of bed partner interventions in 
improving OSA outcomes.  
 
We propose to pilot test a couple-oriented intervention in a randomized controlled trial of 20 
African American patients diagnosed with moderate to severe OSA and their partners. Half of 
the patients will receive optimal usual care currently implemented at MetroHealth, consisting 
of sleep therapist-initiated standardized education about OSA, sleep hygiene, and CPAP use; 
personalized mask fittings; and follow-up at 1 week to troubleshoot problems with CPAP 
utilization. Participants will follow up with their sleep providers per usual. The remaining patients 
and their bed partners will receive a couple-oriented intervention consisting of guideline-
recommended best practices for improving CPAP adherence consisting of sleep therapist-
initiated standardized education for couples about OSA, sleep hygiene, and CPAP use; 
personalized mask fittings; and follow-up at 1 week to troubleshoot problems with CPAP 
utilization. Couples will participate in two couple-oriented support groups led by an African 
American patient with long standing OSA treated with CPAP and their partner. Patients and 
partners will receive tailored text messages encouraging adherence. In addition, couples will 
receive five 60-minute virtual cognitive behavioral couple therapy sessions with a health 
psychologist trained in behavioral sleep medicine that will focus on enhancing couples’ 
knowledge of CPAP, patients’ self-efficacy to use CPAP, couple’s relationship dynamics, 
and partners’ skill and self-efficacy in assisting the patient with CPAP adherence. 
 
Primary Aim 1: To determine the impact of a couple-oriented intervention on CPAP 
adherence. 
Hypothesis:  Compared to usual care patients, patients who receive the couple-oriented 
intervention will use CPAP for more hours per night over 90 days (primary outcome). 
 
Primary Aim 2:  To determine the impact of a couples-oriented intervention on quality of 
sleep, functional status, and quality of life of OSA patients and their partners. 
Hypothesis:  Compared to usual care couples, couples who receive the couple-oriented 
intervention will have a higher quality of sleep, functional status, and quality of life at 90 days 
(secondary outcomes). 

 
 
 
 
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3.0 
Background 
3.01 
 
Many Americans have obstructive sleep apnea (OSA). 
Obstructive sleep apnea (OSA) affects 13% of adult men and 6% of adult women in the US.1 
OSA occurs when the upper airway intermittently narrows or completely closes during sleep, 
resulting in complete or near cessation of breathing for at least 10 seconds at a time.16 
Oscillations in oxygen saturation are common and may fall dangerously low. Snoring may be 
loud and disruptive to others.  These respiratory events cease when the patient partially 
arouses. Partial arousals almost never cause the person to wake completely, but significantly 
decrease the likelihood of obtaining continuous sleep. As a result, OSA is often first recognized 
by bed partners who encourage the patient to seek medical care.17  
 
3.02 
OSA is a cause of significant morbidity and mortality. 
Untreated OSA is associated with motor vehicle accidents and occupational injuries.18,19 Over 
time, the cardiovascular system may become affected leading to the development of 
hypertension,5 coronary artery disease,6,20 atrial fibrillation,21 and sudden cardiac death.22  OSA 
is also associated with the development of ischemic stroke.23 The all-cause mortality hazard 
ratio for untreated OSA compared to no OSA is 3.8 (95% CI 1.6 – 9) after adjustment for age, 
sex, body mass index (BMI), and other factors.24   
 
3.02 
African Americans are at increased risk of being adversely affected by OSA. 
Meta-analyses have found African Americans to have worse subjective and objective sleep and 
to be at increased risk of developing OSA compared to whites.25,26 Studies have found a higher 
severity of OSA among African Americans compared to whites as well as an increase in OSA-
related complications. For example, in the Multi-Ethnic Study of Atherosclerosis (MESA), African 
Americans with an increased risk of OSA had a higher prevalence of inflammatory mediators 
and cardiovascular risk factors compared to other racial and ethnic groups.27,28 
 
3.03 
Continuous Positive Airway Pressure (CPAP) treats moderate and severe OSA. 
CPAP effectively treats OSA by providing a pneumatic splint preventing airway collapse during 
sleep.10–12 It is associated with improvements in quality of life,29–32 and reductions in morbidity.33–
37 By reversing snoring and sleep disruption, CPAP also improves sleep quality among bed 
partners.29,38 There is no threshold duration of use for optimal benefit from CPAP suggesting a 
linear improvement in outcomes with use. While use for more than 4 hours/night improves 
sleepiness and is considered the gold standard duration,39 more than 5 hours/night of use 
improves blood pressure40 and lowers the risk for weight gain.41 More than 6 hours/night of use 
improves memory and daily functioning.42  
 
3.04 
CPAP adherence is low, particularly among African Americans. 
Only about 50% of patients with OSA use CPAP for more than 4 hours per night.42 African 
Americans and patients of lower socioeconomic position have lower adherence compared to 
whites and patients of high socioeconomic position even when adjusting for its cost.43–45 Patient 
adherence soon after CPAP initiation is associated with long-term adherence.46 There are 
differences in symptom recognition, risk perception, and outcome expectations between 
patients who adhere to CPAP and those who do not.47 
 
3.05 
Individual interventions to improve CPAP adherence have had modest results. 
Multiple studies have examined the impact of different interventions on CPAP adherence with 
negative or moderately positive results.48–55 A recent systematic review categorized the 

 
 
 
 
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interventions to determine which had the greatest impact on CPAP adherence.56 
Troubleshooting interventions increased CPAP usage by approximately 40 minutes/night, and 
educational interventions increased CPAP usage by about 50 minutes/night.  Behavioral 
therapy interventions had the largest effect with an increase of 1.31 hours/night. However, the 
quality of the evidence was rated as low. Guidelines encourage use of multifaceted 
interventions that combine educational interventions at CPAP initiation with 
troubleshooting and behavioral interventions during the initial period of accommodating 
to CPAP to maximize adherence.57 In addition, telemonitoring is recommended for early 
identification and intervention among those who are non-adherent. There have been few studies 
that tested interventions among African American patients to specifically address sleep health 
disparities.58,59  
 
2.07 
Bed partners may be an integral component of OSA adherence. 
Randomized trials demonstrate CPAP therapy improves sleepiness and quality of life not only in 
patients, but also their bed partners.60,61 Thus, a couple-based intervention may improve both 
the patient’s OSA and the adverse effects of OSA on the bed partner.62 A qualitative study of 20 
couples by our group identified several facilitators of CPAP use, including couples working 
together to use CPAP, perceived benefit of CPAP to both partners, patients motivated to use 
CPAP for the benefit of partners, and partner support to encourage CPAP use.63 Barriers to use 
included bothersome equipment causing disruptions in sleep and bedtime routine, interruptions 
to intimacy, and concern about a change in body image while wearing CPAP. Sawyer identified 
daily interactions with the partner providing support, assistance with troubleshooting, and 
observing positive response to CPAP in the patient as positive influences on patients’ 
commitments to CPAP.47  
 
2.08  Cognitive behavioral couple therapy (CBCT) may improve OSA adherence. 
Cognitive behavioral couple therapy (CBCT) integrates behavioral couple and cognitive therapy 
to improve communication, problem-solving, and relationship quality among couples.64 CBCT 
focuses on the role of dysfunctional attitudes and attributions on each partner's cognitions, 
behaviors, and emotional responses. Specifically, CBCT assists couples by restructuring 
cognitions that bring in relational distress through unrealistic expectations, irrational beliefs, and 
dysfunctional assumptions. Effectiveness studies of CBCT showed improved relationship 
satisfaction, communication, and problem-solving skills among couples.65 Studies using the 
CBCT approach with patients suffering from PTSD, OCD, vestibulodynia, and cancer, found 
positive improvement in couples' relationships and relationship satisfaction.64,66,67  
 
CBCT has been used previously among OSA patients. In Australia, CBCT was associated with 
a 2.9-hour improvement in CPAP adherence.48 Because cognitive behavioral therapy is the gold 
standard for insomnia management, the expertise delivering this treatment already exists in 
most sleep medicine clinics. It should therefore not be difficult for providers to implement CBCT 
into their OSA management. 
 
2.09 
Preliminary work:  African American patients with OSA and their partners are 
receptive to remote intervention 
We conducted Zoom interviews with 15 African American patients with OSA and their 15 
partners to determine their unique needs regarding OSA management and to determine their 
willingness to receive the intervention remotely. Couples were excited about having a remotely 
administered couples-oriented intervention to improve OSA management. One patient 
commented, “It’s really helpful if the person knows you’re saving your spouse’s life. So yeah, I 

 
 
 
 
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think they should be involved.” Another stated, “She encourages me, and she’s another reason 
why I wear my CPAP.” Couples also suggested that African American couples with experience 
in dealing with OSA and CPAP interact with newly diagnosed patients and their partners to help 
them understand what to expect and how to address problems that arise. One patient stated, 
“When you first start using the machine, it’s going to be uncomfortable.” Another said, “Just 
hearing about the issues… Just even talking like ‘Hey, this is normal’.” These findings were 
used to develop our couple-oriented intervention for African Americans. 
 
2.10 
Innovative features of proposed trial 
Previous studies of CPAP adherence have had little or no involvement of bed partners, short 
follow up durations, small sample sizes, and single interventions. Furthermore, African 
American participation has been extremely limited. There are several unique features that 
distinguish this project from prior work. First, we will recruit African American participants using 
a similar approach to that used to successfully recruit participants in our prior work. Second, we 
will incorporate bed partners into the intervention. Third, our intervention is built on feedback 
received from African American patients and their bed partners. Fourth, African American 
couples with personal experience with OSA will serve as peer motivators. The use of peer 
motivators looks promising.68,69 Fifth, rather than testing single interventions, we propose a 
multi-modality intervention that combines education, troubleshooting, peer motivators, 
continuous telemonitoring, and remote feedback of CPAP use, each of which in isolation have 
been suggested to modestly improve CPAP adherence. 
 
4.0 
Study Endpoints 
Primary Endpoint:   
 
Mean CPAP adherence over 90 days 
 
Secondary Endpoints: 
Mean CPAP adherence over 30 days 
Patient and Bedpartner quality of sleep at 90 days 
Patient and Bedpartner functional status at 90 days 
Patient and Bedpartner quality of life at 90 days 
 
5.0 
Study Intervention/Investigational Agent 
 
5.01 
 
Usual care arm 
Patients in the usual care arm will receive standard of care in the management of OSA. Patients 
will receive care from their sleep provider per usual. MyChart, the patient portal of the electronic 
health record, will be used to send patients a link to user-friendly OSA patient education 
programs (Emmi; Emmi Solutions LLC.).53 Within 1 week of being diagnosed with OSA and 
enrolled in the study, sleep technologists will meet in person with patients and provide them with 
their auto-titrating CPAP machine; train them on its use, upkeep, and troubleshooting; and 
perform personalized mask fittings. Patients will be informed that their CPAP adherence will be 
monitored. Every morning, CPAP adherence data will be uploaded to RedCap. Patients with 
CPAP technical difficulties will be encouraged to contact the sleep technologist for assistance. 
Patients will attend a 90-minute virtual webinar and question-answer session on hypertension 
management, cancer screening, or weight management at 1 and 3 months led by African 
American physicians with expertise in each topic. 
 
5.01a Virtual sleep logs as ecological momentary assessments. Patients will be asked 
whether they would prefer to receive communications via telephone, email, text message, or a 

 
 
 
 
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combination. During the first 6 months of the study, patients and bed partners will receive up to 
4 interactive text messages/week in the morning inquiring about the quality of their sleep, their 
sleep-wake patterns, symptoms attributable to OSA, perceptions regarding OSA and CPAP, 
what time they went to sleep, when they woke up for the final time, how they rated the quality of 
their sleep, and any additional comments they may have.70,71 
 
5.02 
 
Couple-oriented intervention arm 
 
5.02a Peer-Motivator Couples. Patients in the couple-oriented intervention arm will also 
receive usual care. However, the health-related virtual webinars at 1 and 3 months will be 
replaced by OSA virtual support groups led by an African American patient with long-standing 
OSA and their bed partner. Peer-motivator couples will be trained and certified as competent 
prior to interacting with study participants. They will share their experiences with managing OSA 
including coping strategies to maximize CPAP adherence. 
 
5.02b Telemonitoring. Physiologic and adherence data from patients’ CPAP machines will be 
uploaded into RedCap and used to automatically trigger messages of encouragement to 
patients and partners. For the first three days following receipt of CPAP, patients and bed 
partners will each receive text messages regarding CPAP use for the previous night. Similar 
messages will be received after the first study week with 3 nights of consecutive use (or lack of 
use). No more than 4 messages will be sent per week to prevent respondent fatigue. Example 
messages include: 
 
Trigger 
Patient Message 
Bed Partner Message 
CPAP use < 4 hours per night in any of 
the first 3 nights of the study 
Did you have any difficulty using CPAP 
last night? What changes can you make 
to increase your use tonight? 
Did your partner had trouble using 
CPAP last night? How can you help 
them use it tonight? 
CPAP use > 4 hours per night in any of 
the first 3 nights of the study 
Congratulations on wearing your CPAP 
last night. Let’s see if you can do it again 
tonight! 
Your partner was able to wear their 
CPAP tonight. How can you help them 
to use it again tonight? 
CPAP use < 4 hour per night for 3 
consecutive nights (first occurrence) 
It takes some time to get use to CPAP. 
However, regular use can improve your 
sleepiness and your wellbeing. Can you 
try again tonight? 
Your partner has not reached their 
CPAP goal for the last 3 nights. What 
are some ways to help them use it 
tonight? 
CPAP use > 4 hours per night for 3 
consecutive nights (first occurrence) 
Way to reach your sleep goal 3 nights in 
a row! 
Can you do it again tonight? 
Your partner has reached their CPAP 
goal 3 nights in a row! Can you 
encourage them again tonight? 
 
5.02c Cognitive Behavioral Couple Therapy (CBCT). A psychologist will facilitate two virtual 
60-minute CBCT sessions. Virtual psychotherapy for couples is both efficacious and feasible.72 
The therapy process will be based on the principles of psychology and chronic illness, the 
reciprocal association between the couple’s functioning and the issues related to OSA.73 These 
sessions will consist of four main components: problem-solving training, communication training, 
cognitive restructuring, and functional structuring of the couple’s relationship. Dr. Burger will 
have a not-guiding stance towards a preconceived thought but will facilitate open exploration 
and problem solving.  
 

 
 
 
 
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Each session will begin with review of assigned tasks from the prior session. Couples and 
therapist will review the digital sleep logs and CPAP adherence data. They will then problem-
solve ways to improve CPAP adherence. Dr. Burger will use guided discovery with Socratic 
questioning to facilitate couples’ exploration of automatic thoughts, emotions, assumptions, and 
beliefs. Behavioral experiments will be used to help couples test the validity of their cognitions 
and beliefs and to promote awareness of the way they perceive and react to events and to each 
other. Couples will be encouraged to continue the experiments in their daily lives outside of the 
sessions. Sessions will conclude with assigned homework to be completed by the couple prior 
to the subsequent session. Prior to ending the session, couples will be asked to comment on 
whether they received the help they needed for that day and whether they felt fully understood. 
The final session will have discussion of the positive effects resulting from having OSA (benefit 
finding), a review of the progress made in therapy, and the challenges that lie ahead. 
 
SESSION 
SESSION GOALS 
174 
-Introduction to cognitive behavioral couples’ therapy 
-Review of goals of therapy 
-Collaborative setting of agenda by therapist and couple 
-Discuss baseline digital sleep log data  
-Review recommendations for optimal sleep hygiene 
-Review tasks to be completed for next session (continue sleep log completion and review sleep hygiene 
recommendations) 
2 
-Conceptualize OSA as a multidimensional problem 
-Identify cognitive, emotional, reciprocal influences, and environmental factors affecting couples’ functioning 
-Discuss cognitive distortions and communication 
-Improve adaptive coping through improving self-efficacy and working with cognitive distortions such as 
maximization and castrophizing 
-Benefit finding 
-Relapse prevention 
-Consolidate skills 
 
6.0 
Procedures Involved 
This is a pilot randomized controlled trial involving 20 African American patients with OSA and 
their bed partners. Patients will be identified within 48 hours of a new diagnosis of moderate to 
severe OSA and planned prescription of CPAP by their providers. Patients will be randomized to 
a usual care arm or a couple-oriented intervention arm and complete the tasks below. All 
patients will receive auto-titrating CPAP machines equipped with cellular modems upon 
enrollment into the study. Every morning the machines will use cellular communications to 
upload physiologic data (CPAP adherence, applied CPAP pressure, mask leak, and residual 
respiratory events) to RedCap. Ecological momentary assessments (EMA) in the form of 
morning text message will allow patients and partners to report their sleep quality and CPAP 
experiences in the mornings over the first 6 weeks of enrollment.75 Shortly after waking, patients 
and their bed partners will receive automated interactive text messages up to 4 times per week 
asking them about their sleep duration, quality, and experiences with CPAP from the prior night. 
Their responses will be uploaded directly into RedCap for comparison to nightly CPAP machine 
usage reports. Couples in the intervention arm will receive automated text messages when their 
CPAP usage drops below designated thresholds or when there is substantial improvement in 
CPAP adherence.53 Mosio text messaging software will be used to automatically send and 
receive text messages between study participants and RedCap. 

 
 
 
 
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STUDY TASKS 
USUAL CARE ARM 
COUPLE-ORIENTED INTERVENTION 
ARM 
Care from sleep providers 
- Order CPAP 
- Counsel patient about OSA diagnosis 
- Order CPAP 
- Counsel patient about OSA diagnosis 
Care from study sleep 
technologists 
-  Standardized review of sleep study, auto-
CPAP instruction and troubleshooting, 
and mask-fitting with patient 
-  Standardized phone call with patient 1 
week later to answer questions and 
address any problems that arose 
-  Meet with patient as needed to 
troubleshoot problems 
-  Standardized review of sleep study, auto-
CPAP instruction and troubleshooting, 
and mask-fitting with patient and partner 
- Standardized phone call with patient and 
partner 1 week later to answer questions 
and address any problems that arose  
-  Meet with patient and partner as needed 
to troubleshoot problems 
Care from experienced African 
American patient with OSA and 
bed partner (peer motivators) 
- Two health talks moderated by African 
American health care providers 
- Two support group sessions for African 
American patients and their partners to 
assist with OSA and CPAP 
Automated telehealth care  
Not applicable 
- Daily review of CPAP adherence data 
- Contact patient and partner when any of 
the following is present: no data 
uploaded from CPAP machine in > 72 
hours, mask leak > 40L/min > 30% of 
night, < 4hr of use for 3 consecutive 
nights, machine measured AHI > 
10events/hr, & 90% of pressure > 
16cmH2O.50 
- Contact patient and partner when CPAP 
use exceeded 4hr for 3 consecutive 
nights.53  
 
We expect about 55% of the participants will be women, 94% will be African American non-
Hispanic, and 6% will be African American and Hispanic.  
 
 
Patient demographic and medical characteristics (e.g., comorbid conditions) will be obtained 
directly from EpicCare. Socioeconomic status will be assessed by asking patients about their 
education, occupation, and income. Patient and bed partner relationship quality will be 
assessed using the 4-item version of the Dyadic Adjustment Scale (DAS-4), one of the most 
widely used measures of couple satisfaction in research and clinical practice.76 The 6-item Zarit 
Burden Interview for Dementia Caregivers is one of the most widely used measures of caregiver 
burden.77 OSA severity will be assessed using the apnea-hypopnea index, the time spent with 
oxyhemoglobin saturation < 90%, and the lowest value of oxyhemoglobin saturation each 
retrieved from the polysomnogram report.78 All participants will be given an autotitrating CPAP 
machine that can be monitored remotely. The device will upload objective adherence data to 
RedCap each morning following use. Adherence is the average nightly use of CPAP from 
baseline to designated follow-up times (30 days, 90 days).  
 
Instruments to measure OSA knowledge and beliefs, depression, sleepiness, quality of sleep, 
quality of life, self-efficacy to use CPAP, and degree of bed partner involvement in CPAP 
adherence will be completed by all study participants at baseline, 30 days, and 90 days. 
These instruments have demonstrated reliability and validity and have been used in previous 

 
 
 
 
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studies of OSA and CPAP adherence. Depression, a potential factor confounding the 
relationship between the presence of sleep apnea and CPAP adherence, will be assessed using 
the 9 item Patient Health Questionnaire (PHQ-9).79 It performs well among diverse patient 
populations.80 The 8-item Epworth Sleepiness Scale (ESS) measures the propensity to fall 
asleep in eight unique situations.81 Scores on the ESS are positively associated with OSA 
severity,82 and they improve with CPAP treatment. The 8-item short version of PROMIS Sleep 
Disturbance Index will be used to assess self-reported perceptions of sleep quality, sleep depth, 
and sleep restoration. It has greater measurement precision than the ESS and the Pittsburgh 
Sleep Quality Index.83 The impact of sleepiness on functional status will be assessed using the 
10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10). Quality of life will be 
assessed with the 12-item Medical Outcome Survey Short Form (SF-12).84 Sleep-related quality 
of life will be assessed using the Calgary Sleep Apnea Quality of Life Index (SAQLI). Self-
efficacy, or confidence in one’s ability to use CPAP when faced with difficulties, will be assessed 
using the Self Efficacy Measure in Sleep Apnea (SEMSA). 

 
 
 
 
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DATA ELEMENT 
SOURCE 
- Patient and bed partner demographic and clinical characteristics: 
age, gender, race, ethnicity, socioeconomic status, comorbidities, 
sedative and psychoactive medications 
- Electronic health record and questionnaire 
- Bed partner involvement 
- Patient and bed partner texts about sleep quality 
- Bed partner burden 
- Zarit Burden Interview (6-item) 
- Patient and bed partner relationship quality 
- 4-Item Dyadic Adjustment Scale (DAS-4) 
- OSA severity (apnea-hypopnea index, duration of oxygen 
hemoglobin saturation < 90%, oxygen hemoglobin saturation 
nadir) 
- Sleep study reports from electronic health record 
- CPAP settings and proper interface 
- CPAP machine download 
- CPAP adherence 
- CPAP machine daily download 
- Depression 
- Patient Health Questionnaire 9-item Depression Scale 
(PHQ-9) 
- Excessive daytime sleepiness 
- Epworth Sleepiness Scale (ESS) 
- Sleep quality 
- PROMIS Sleep Disturbance Index (PSQI) 
- Impact of sleepiness on functional status 
- Functional Outcomes of Sleep Questionnaire short 
version (FOSQ-10) 
- General quality of life 
- SF-12 questionnaire 
- Sleep apnea-related quality of life 
- Calgary Sleep Apnea Quality of Life Index 
- Self-efficacy to use CPAP 
- Self-Efficacy Measure in Sleep Apnea (SEMSA) 
 
7.0 
Data and Specimen Banking 
 
Not Applicable. 
 
8.0 
Sharing of Results with Subjects 
Results from the study will be shared through the publication of findings in research 
journals and via presentation at scientific meetings. Results will be directly shared with 
participants upon inquiry. 
9.0 
Study Timelines 
Participants will be enrolled from April 1, 2022 to December 31, 2022. Participants will 
participate in the study for 90 days. The estimated date for primary analysis to be completed will 
be March 1, 2023. 
 
10.0 Inclusion and Exclusion Criteria 
We will focus on eligible patients with moderate or severe OSA as CPAP is first-line therapy for 
this population. Because of their similar performance, sleep studies will be performed in 
patients’ homes85,86 or in the sleep centers of The MetroHealth System and will be interpreted 
by registered polysomnographic technologists using standard criteria.87 Split night studies will 
be eligible for inclusion. We will focus on adults as the causes and treatments for OSA are often 
different in children. To maximize the chances that patients will continue to have the same bed 
partner throughout the duration of the study, we will only include couples who have been bed 
partners for at least 6 months. We will focus on English-proficient patients as study interventions 
have been tailored for English-proficient patients and their bed partners and there are relatively 
few Spanish-speaking patients in our area. We will exclude patients with conditions that may 
interfere with their participation or alter their management of OSA. We will also exclude patients 
who have more complex forms of sleep-disordered breathing requiring other forms of positive 
airway pressure. 

 
 
 
 
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SCREENING INCLUSION CRITERIA 
EXCLUSION CRITERIA 
-Moderate or severe OSA (Apnea hypopnea index ≥ 15 
events/hour) 
-Terminal illness 
-Age ≥ 18 years 
-Mentally incompetent 
-Bed partner for ≥ last 6 months who is willing to participate 
-Unstable housing 
-English proficient 
-Need for other forms of positive airway pressure (BPAP or VPAP) 
 
11.0 Vulnerable Populations 
 
This study will not enroll vulnerable populations. 
 
12.0 Local Number of Subjects 
This study will enroll 20 African American patients of MetroHealth with OSA and their bed 
partners.  
 
13.0 Recruitment Methods 
Prior to enrollment of the first subject, sealed envelopes containing participant computer-
randomized study arm assignment will be created. To assure balanced but unpredictable 
assignments of participants we will use permuted block randomization, stratified by study 
site.88,89 Study flyers will be distributed to sleep providers to distribute to eligible patients who 
can contact study staff for enrollment. Research assistants will obtain automated digital reports 
from EpicCare of patients who have received an at-home or in-lab diagnostic sleep study over 
the previous 48 hours and an order for initiation of CPAP. They will review EpicCare to verify 
eligibility (see Table above). Study staff will mail a study brochure and consent form to patients. 
Those who do not respond within 72 hours will receive a phone call to confirm patient and bed 
partner eligibility and to explain the study in detail. Upon obtaining verbal confirmation, staff will 
arrange a date and time to meet with patients and their bed partners in person to obtain written 
consent and to administer baseline study instruments. After completion of these initial tasks, 
staff will open envelopes to determine subject study arm assignment. Only the sleep 
technologist, the research assistants who enroll the patients and the participants will be aware 
of study arm assignments. Participants will receive Clincard payments within 1 week of 
completion of study tasks. Participants will receive $50 for completion of the baseline, 30-day, 
and 90-day instruments ($150 total / participant paid by ClinCard). Participants will also be 
reimbursed for public transportation or parking. 
 
14.0 Withdrawal of Subjects 
Participants will not be withdrawn from the research without their consent. Participants 
who withdraw from the study will be able to keep their CPAP machine and will continue 
to receive care at MetroHealth per usual. Their data collected up to the time of 
withdrawal from the study will continue to be used according to intention to treat 
methodology. 
15.0 Risks to Subjects 
Potential risks to participants are (a) discomfort with sleep technologist interactions and (b) 
breaches of confidentiality. Precautions to minimize these risks are described below. The only 
alternative is to no participate in the study. However, patients may refuse to interact with study 
staff, decline to follow their advice, or withdraw from the study at any time.  
 

 
 
 
 
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All interactions with subjects will occur within the MetroHealth System where they receive 
care. As a result, all the usual approaches to maintain privacy and confidentiality in the health 
care setting will be observed. We will immediately notify the patients’ primary care provider if 
they are suicidal at any time during the trial so that urgent evaluation and treatment can be 
arranged.  
 
To protect against beaches of confidentiality, all study-related data to be secured on the 
password- and firewall-protected servers of The MetroHealth System.  These servers are 
continuously backed up.  No participant identifying data will be released or reported publicly. 
 
The project manager and research assistants will have password-protected laptops with 
encrypted storage to enter study data into RedCap, the secure web-based database manager 
residing on the servers of The MetroHealth System.  No data will reside directly on the laptops, 
but instated will be backed up to the secure, private servers of The MetroHealth System. These 
servers are protected by MetroHealth’s firewall. Mosio will use HIPAA compliant procedures to 
securely send and receive data between study participants and RedCap. 
 
16.0 Potential Benefits to Subjects 
The risks of the proposed study are minimal as discussed above. Our proposed intervention is 
designed to improve CPAP adherence among patients with moderate and severe OSA. This 
approach may lead not only to improved sleep quality for patients and their bed partners, but 
increased functional status, and increased quality of life.  
Participants will receive a CPAP machine and supplies that they keep upon conclusion 
of the study. They will also receive access to CPAP machine and equipment 
management. 
 
17.0 Data Management and Confidentiality 
 
Our study database will be stored in RedCap (https://www.project-redcap.org),90 a secure, 
open-source software application regularly utilized by Dr. Thornton’s research teams. RedCap 
runs on the MetroHealth server and therefore is HIPAA compliant, provides user-specific data 
access, and facilitates removal of participant identifying data prior to exporting. It also facilitates 
double data entry with real-time data validation and data integrity checks. Patient data will be 
entered directly into the RedCap. Study data will be held for 7 years following study completion. 
Paper records will be stored in locked filing cabinets within the Center for Reducing Health 
Disparities (Rammelkamp R209). Mosio will use HIPAA compliant procedures to securely send 
and receive data between study participants and RedCap. 
 
Because this is a pilot study, a power calculation is not provided. 
 
We will begin our analysis by computing descriptive statistics and using graphical 
representations to examine all predictor and outcome variables.  For each study patient, the 
primary outcome will be CPAP adherence at 90 days as determined by the mean daily CPAP 
usage (the total number of hours of CPAP use divided by the number of days observed for the 

 
 
 
 
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individual). An intention to treat analytic approach will compare mean daily CPAP usage 
between intervention and control patients as randomized. Linear mixed effects models using 
random effects will be used to adjust for clustering of patients within sleep provider. Covariates 
(fixed effects) will include indicator variables for BMI, AHI, gender, and treatment.89 The model 
assumption that the overall CPAP usage outcome is normally distributed will be tested using the 
Shapiro-Wilk test.  If a significant departure from normality is obtained (and a suitable 
transformation, such as log, is not found) an alternative approach will be to use a generalized 
linear (e.g., Poisson regression) model for the overall adherence (CPAP usage rate). A Wald 
test (with robust estimate of standard error) will be used to test for an intervention effect and a 
corresponding 95% confidence interval for the intervention effect will be computed. If substantial 
variability in follow-up times are found (e.g., due to dropout and/or missed visits), a weighting 
approach (using weights proportional to the number of days observed for each individual in 
conjunction with the selected model) can be used. 
 
We will perform primary and secondary analyses like those for Aim 1.  However, the outcome 
variables for Aim 2 analyses will be scales and subscales related to quality of sleep (Epworth 
Sleepiness Scale, PROMIS Sleep Disturbance Index), functional status (Functional Outcomes 
of Sleep Questionnaire short version), and quality of life (SF-12, Calgary Sleep Apnea Quality of 
Life Index) for both patients and their bed partners.  If these outcome variables are not normally 
distributed, we will use proportional odds with random effects by study site and sleep provider to 
test differences in these ordinal data between arms.91 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
We propose several methods to ensure safety and to monitor our intervention. First, our 
intervention is theoretically sound and based on our prior work and that of others. Second, the 
principal investigator will meet weekly with other study personnel to trouble-shoot any potential 
areas of concern regarding the safety of the study protocol. Third, all study staff will undergo 
rigorous training.  Fourth, the principal investigator will closely monitor study staff through a 
combination of regular meetings, monitoring of data collection, and direct observation. Fifth, 
project data will be reviewed quarterly by the entire study team.  
Any indications of potential threats to patient safety or a pattern of refusal by patients to 
participate in specific study tasks will be responded to immediately by a careful review 
conducted by the study team.  When appropriate, the patient’s physician, reporting to the 
Institutional Review Board of The MetroHealth System, and adjustment to the study protocol will 
occur.  Although risks to subjects is considered minimal, any adverse events will be reported to 
the Institutional Review Board of The MetroHealth System and the National Institutes of Health. 
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
All study-related data to be secured on the password- and firewall-protected servers of The 
MetroHealth System.  These servers are continuously backed up.  No participant identifying 
data will be released or reported publicly. 
 
The project manager and research assistants will have password-protected laptops with 
encrypted storage to enter study data into RedCap, the secure web-based database manager 
residing on the servers of The MetroHealth System. No data will reside directly on the laptops, 
but instated will be backed up to the secure, private servers of The MetroHealth System. These 
servers are protected by each institution’s firewall. 

 
 
 
 
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20.0 Compensation for Research-Related Injury 
This is a minimal risk study. No compensation will be provided in the event of research 
related injury. Patients will receive care from The MetroHealth System per usual. 
21.0 Economic Burden to Subjects 
Participants receive study compensation and are reimbursed for parking and 
transportation costs to complete study instruments. No additional economic burden is 
anticipated. 
22.0 Consent Process 
Each day, research assistants will review electronic health record-generated reports of patients 
who received a diagnostic sleep study over the previous 48 hours and a prescription for CPAP 
from their provider. Assistants will review the electronic health record of each patient to confirm 
eligibility. They will then mail a study brochure and consent form to patients. Those patients that 
do not respond by 72 hours will be contacted to confirm that both the patient and bed partner 
are eligible and to explain the study in greater detail. After obtaining verbal confirmation, the 
staff will schedule a date and time to meet with patients and their bed partners at MetroHealth to 
fully explain the study, address any questions that patients and partners may have, obtain 
written consent, and administer baseline study instruments using the IRBs standard operating 
procedures.  Following completion of these tasks, staff will open premade sealed envelopes to 
determine subject study arm assignment.  
 
23.0 Process to Document Consent in Writing 
The IRB’s standard operating procedures will be used to document written consent and to 
obtain HIPAA Authorization. 
 
24.0 Setting 
This study takes place virtually among patients of the MetroHealth System. Study 
interventions will be administered online while study instruments will be completed in 
person at The MetroHealth System (within the Population Health Research Institute or 
Clinical Research Unit). 
25.0 Resources Available 
The study will be conducted from the research space of the Center for Reducing Health 
Disparities. The Center has all the necessary resources to successfully conduct this 
project. Dr. Thornton and his research team have received funding from NIH to provide 
sufficient time to complete the project. All members of the team have been involved in 
the design of the study protocol and are aware of their duties to carry out research 
procedures.  
The MetroHealth System has ample number of patients from which to recruit. 
 
 
Sleep 
Providers 
Eligible 
Patients 
Mean  
Age ± 
SD 
Percent 
Female  
Percent  
African 
American 
Percent 
Married 
Mean  
AHI ± SD 
The MetroHealth 
System 
7 
1,453 
48 ± 14 
59% 
40% 
36% 
27 ± 27 
 

 
 
 
 
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