Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence: A Randomized Controlled Trial
Phase: NA
Conditions: Sleep Apnea
Sponsor: The Cleveland Clinic

 
 
 
 
 
Impact of a Novel Sleep Apnea Management Group Intervention on 
Positive Airway Pressure Adherence: A Randomized Controlled Trial 
 
NCT03835702 
 
Study Protocol and Statistical Analysis Plan 
 
Document Date: 8/14/2019 
 
Uploaded: 11/22/2019 
 

 
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8/14/2019, Ver3 
Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure 
Adherence: A Randomized Controlled Trial 
 
Introduction 
SPECIFIC AIMS:  Obstructive Sleep Apnea (OSA) affects ~10-15% of the adult population in the United States 
and when present to a moderate to severe degree is associated not only with decrements in quality of life, but 
also increased cardiovascular risk and a 2-fold increase in mortality.  Positive Airway Pressure (PAP) is the 
mainstay treatment for OSA. Suboptimal PAP adherence (only 40-70% of patients are adherent) poses a 
continued substantial threat limiting ability to mitigate the negative consequences of untreated OSA. PAP 
adherence is therefore an essential focus of clinical management that requires persistent monitoring and 
practical problem solving, as too many patients derive suboptimal medical and psychological benefits due to 
their insufficient use of this proven therapy. Indeed, even clinical trials have demonstrated suboptimal PAP 
adherence despite intense observation thereby limiting ability to effectively interpret results. There is evidence 
that frequent patient contact to troubleshoot seemingly mundane problems contributes to improved adherence. 
Preliminary evidence demonstrates benefit through attendance of a group clinic designed to encourage patient 
adherence with PAP therapy as it provides a simple and effective means of improving treatment of OSA, 
however randomized controlled trials, are sorely needed to extend this evidence and inform patient care.  
Background and Significance 
 
The Sleep Apnea Management Clinic (SAM) is a novel group clinic created and embedded in the 
Cleveland Clinic (CC) System to address challenges in positive airway pressure (PAP) management by 
promoting adherence via providing access to problem-solving of PAP therapy issues. This innovative and 
interactive format allows patients with common problems and needs to have direct access to sleep medicine 
providers, sleep nurse practitioners, sleep nurses and/or durable medical equipment (DME) representatives all 
in one room in order to receive the most efficient service. While there are limited data focused on examining 
group clinics for PAP education, there are scant data that have assessed PAP adherence and its barriers in a 
group setting. Our team has played an integral role in the design, development, and establishment of the SAM 
Clinic initiative and has extensive experience in its management and operations. We propose a randomized 
controlled trial, involving 83 patients in SAM clinic and 83 patients in usual care and compare PAP adherence, 
patient reported outcomes and PAP barriers. Expected results will be of high impact given ability to identify and 
inform future treatment approaches for management of OSA with PAP and identify key outcomes for clinical 
trials. In doing so, this line of investigation will likely have a significant clinical impact to enhance PAP 
adherence and ameliorate adverse clinical outcomes associated with OSA patient populations across systems 
of care. 
 
Specific Aims  
SA 1. To examine the impact of the sleep apnea management (SAM) group-based intervention on 
Positive Airway Pressure (PAP) adherence (primary outcome) compared to a patient group managed 
by physicians (patients who follow usual care and are receptive to the SAM Clinic but do not 
participate in a SAM group) on changes from baseline to 1 and 3 months in those with moderate to 
severe OSA with suboptimal PAP adherence.  
Hypothesis 1: We hypothesize that the SAM clinic intervention will result in improved PAP adherence versus 
usual care. 
SA 2. To examine and compare changes in patient reported outcomes (PROs, i.e. daytime sleepiness, 
quality of life measures, and depressive symptoms) between the SAM Clinic and the usual care arms 
from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP 
adherence. To examine the correlation between changes in PROs to changes in PAP adherence at 
each time point (secondary analyses).  
We hypothesize that greater improvement in PROs will be noted with the SAM clinic intervention compared to 
usual care. 

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significant degree. 
 
Study Design 
METHODS, INCLUDING EVALUATION METHODOLOGY AND DATA ANALYSIS PLAN 
Recruitment Strategy: Trained personnel who have completed the necessary certification for human subject 
research will screen a patient list of those prescribed with new PAP within 2-4 weeks by providers will be 
obtained weekly from the Cleveland Clinic Durable Medical Equipment (DME) company. PAP adherence will 
be ascertained using Encore/My air software®.  Patients with suboptimal adherence, defined by the Center of 
Medicare and Medicaid criteria (<70 % usage and <4 hours of average daily PAP usage) will be identified. The 
referring providers will be contacted via email/phone/staff message to explain the study protocol and to obtain 
permission for each patient to be contacted to participate in the study. After obtaining permission from the 
referring provider, an introduction letter will be sent and the purpose of the research will be explained and a 
copy of the consent will be mailed to the subject with self-addressed stamped envelopes. The recruiter will 
then call the patient to review the consent and answer any questions. The participant may request an in-person 
consenting process, which the recruiter will accommodate. After the signed consent is returned to the recruiter, 
they will sign as witness and document.  
 
A written waiver of consent will be requested (according to 45 CFR46.117) to collect and review health 
information about prospective subjects prior to obtaining written informed consent.  The research 
involves no more than minimal risk.  The waiver will not adversely affect the rights and welfare of the subjects 
and the research could not be conducted without the waiver because the health information collected is 
necessary to ascertain which subjects are eligible to participate in the study. 
 
This is a request for partial waiver of HIPAA authorization” to collect health information” from medical records 
of identified by Cleveland Clinic Durable Medical Equipment (DME) company by Medical Record Number. This 
will be done by accessing each potentially eligible patient’s electronic chart only once in order to review the 
most recent note from the patient’s physician. Information viewed will be used by the study recruiter to check 
yes or no on the study inclusion and exclusion criteria form with no recording of specific results being made. 
These forms are de-identified with only the study id listed. No printouts from the Portal will be made. Review of 
the chart should take no more than 5 minutes per patient.  Once a person has been identified as eligible to 
participate in the study, they will be a recruitment letter introducing the study along with a copy of the consent.   
All hard copies of this health information will be destroyed about all patients who do not meet study criteria and 
those who decline participation. All personal health information collected and retained on site prior to obtaining 
written authorization will be de-linked from identifying personal information.  Also, if written authorization is not 
obtained within 90 days of patients who have agreed to participate in the study, their health information will be 
destroyed. 
 
Eligibility criteria: Inclusion Criteria: 1) >18 years old 2) Moderate to severe OSA (apnea hypopnea index 
(AHI), respiratory disturbance index (RDI), Respiratory Event Index (REI)>5 events/hr) on polysomnogram 
(PSG) or home sleep apnea testing (HSAT) 3) Followed by non-sleep and sleep providers for OSA 4) New 
PAP set up < 1 month 5) Sub-optimal PAP adherence by objective PAP adherence data (<70 % usage and <4 
hours of average PAP usage)   Exclusion criteria:  1) Central sleep apnea (>50% apneas are central) and/or 
presence of Cheyne-Stokes breathing 2)  Pregnant women 3) Patients on supplemental oxygen 4) Patients not 
able to attend SAM clinic 5) Inability to provide informed consent  
 
Randomization: Patients will be randomized 1:1 to SAM clinic/sleep hygiene or usual care/sleep hygiene 
(care by non-sleep providers) using a blocked randomization that stratifies patients based on OSA severity 
(AHI, RDI, REI 5-14.9, 15-29.9 vs. AHI, RDI, REI  >30+). Random assignments to the three arms will be made 

 
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with the use of a randomization database in REDcap.   
 
Study Protocol:  .  All data from PAP devices set up by CCDME will be downloaded via wireless 
communication or smartcard. PAP adherence will be monitored by the research coordinator before 
randomization (randomized to SAM Clinic or usual care with their provider) and after 1 and 3 month of either 
intervention. A sample size of approximately 83 subjects is estimated in each group over a period of 2 years 
(total n=166). SAM clinic appointment will be offered within 1-2 weeks of patient consent and randomization 
into that group.  Both groups will be provided with PAP barriers questionnaires which will be administered in 
“yes/no” format focused upon specific mask issues (air leak, irritation, fitting problems, type of mask) and other 
issues (nasal congestion, claustrophobia etc.) and the same questionnaires will be instituted in both the groups 
at the 1- and 3-month follow-up through the email using redcap platform. See Figure 2 for the flow diagram of 
the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sleep Hygiene Education: A research coordinator will provide both the arms with sleep hygiene education 
material at baseline that entails regularization of sleep wake schedule, stimulus control education, adequate 
amount of sleep and comfortable environment conducive to sleep (by mail). 
 
OSA Patients with sub-optimal PAP adherence prescribed new 
PAP therapy within 1 month by provider 
Informed consent obtained from eligible patients 
Randomization 
SAM Clinic/Sleep 
Hygiene Group 
Usual Care/Sleep 
Hygiene Group 
Baseline Visit, 1 Month Visit, and 3 Month Visit: 
Objective PAP Adherence Data Obtained, PAP Barrier 
Questionnaires, and PRO Questions 
Figure  2: Flow Diagram of Study 

 
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SAM clinic Intervention: See 
Figure 3 for depiction of SAM 
clinic visit process. Typically 8-
10 patients are scheduled in 
SAM clinic, during which a sleep 
provider led team comprised of 
either a sleep clinician or sleep 
nurse practitioner along with 
DME representative(s). Each 
session begins with a discussion 
about OSA and PAP. The 
provider interacts with each 
patient personally.  This occurs 
on weekly basis at main and 
other selected regional locations 
of CC.  Various modes of trouble 
shooting of PAP related issues 
are tailored to solve PAP 
adherence issues including 
mask complaints, nasal issues, pressure intolerance, anxiety, and other related barriers to PAP adherence. 
Different interface masks might be provided during the visit depending on the clinical situation (e.g 
those with claustrophobia will be given nasal pillows). When the provider is seeing patients individually 
other patients have the opportunity to interact and offer informal interpersonal support to other participants in 
dealing with similar PAP related issues. The provider makes an individualized follow-up plan for each patient, 
which may include another SAM visit or referral back to the non-sleep provider. 
Usual Care: The control arm will receive usual routine care.  Patients will follow-up only with their provider for 
the monitoring of PAP adherence issues. The follow up visit is usually scheduled1-3 months of the PAP set up 
and further follow up is contingent upon the clinical scenario of the patient. The usual arm care patients will be 
recommended to make a follow up appointment with their provider by the research coordinator, if not already 
scheduled.  
 
Data Collection: Data related to PAP barrier questionnaire, PAP adherence, BAS-FS personality index, 
physiological measurements, PROs (mentioned below) will be collected and entered into the REDcap 
database of Cleveland Clinic (secured database). 
 
Procedures: The RedCap program is a scalable electronic platform to systematically collect patient-reported 
data through a mobile ready web-based data collection system. Invitation(s) to complete questionnaires will be 
sent to patients’ email with a link to PAP barrier questionnaire and PROs.  Enrolled patients can complete 
these remotely at pre-specified time-points (within a week of enrollment) that are independent from a clinical 
encounter. The Redcap sends automated reminders and collects management and performance statistics.  
When each question is completed, real-time data is captured by the RedCap data warehouse.  
 
PRO Questionnaires:  Epworth Sleepiness Scale (ESS) is an 8-item questionnaire and the most widely used 
tool for measuring subjective sleepiness.  An ESS of >10 indicate daytime sleepiness  
Patient Health Questionnaire-9 (PHQ-9) is a 9-item depression scale that provides psychometric measurement 
of depression. A score of >10 indicate moderate to severe depression.  
Promis Global Health is a 10-item questionnaire measuring patient reported health status for physical, mental, 
and social well-being. 
Promis Sleep Related Impairment is an 8 item questionnaire used to identify problems in sleep that affect 
overall quality of sleep. 
Promis Fatigue is an 8 item questionnaire that evaluates self-reported symptoms tiredness that affect daily 
activities and functioning. 
Promis Anxiety is a 4-item questionnaire to evaluate anxiety. 
 

 
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Data Analysis Plan: Patients will be randomized 1:1 to the two treatment groups using a blocked 
randomization that stratifies patients based on OSA severity (AHI, RDI, REI 5-15 vs.15-30, 30+).  Blocks will 
be of random size blinded from study investigators. Only the intent-to-treat population will be included in 
primary analyses, while secondary analyses will be performed in the per-protocol population defined by 
participation in the SAM Clinic for the treated group versus usual care patients. Linear and non-linear mixed 
effect models will be used to compare groups for changes in PAP adherence (primary endpoint), PROs, and 
barriers over time.  In these models, group by time interactions will be used to evaluate trend differences 
between groups, and mean differences primarily at 3 months and secondarily at 1 month.  The use of mixed 
effect models will account for loss to follow-up under the assumption that such dropout is missing at random, 
though this assumption will be evaluated graphically.  If data are missing not at random, pattern mixture 
models will be further explored to evaluate group differences.  Analyses will be performed assuming an overall 
significance level of 0.05, and comparisons of mean differences at 1 and 3 months will each use a 0.05 
significance level. Statistical support will be provided by a biostatistician within the Cleveland Clinic Department 
of Quantitative Health Sciences for this project. 
 
Sample Size: Sample size calculations were performed based on detecting mean differences in PAP 
adherence at 1 and 3 months.  In this study, patients undergoing motivational enhancement (ME) showed an 
average PAP adherence of 264 minutes (SD: 174) as compared to average PAP adherence of 198 (SD: 168) 
among those without ME.  Given the overall paucity of data addressing PAP adherence in a group setting-we 
utilized this data from RCT with ME given the similarities in approach. If we assume a similar effect size, and 
assume that average adherence will be log-normally distributed with a coefficient of variation of 0.65, there will 
be 80% power to detect an increase of 33% in the mean average nightly PAP adherence with 67 patients per 
group.  Allowing for non-participation and non-compliance rates of 10% in each group, a total of 83 patients per 
group will be enrolled, the adjustment described by Lachin. This sample size will also provide similar power to 
detect moderate effect size differences between study groups on PROs, even allowing for dropout on these 
measures of up to 20% on these measures.   Power calculations were performed using SAS software (version 
9.4; Cary, NC) and assumed use of a two-sided test with significance levels of 0.05. 
 
Limitations/Pitfalls and Alternative Strategies: Since this is a comparative study comparing the 
effectiveness of SAM clinic to usual standard of care by providers, there are inherent limitations to such a 
design. There is a possibility of cross over for the patients. We have accounted for possible cross-
contamination in the statistical design by increasing the sample size. Patient without email access will be sent 
paper format of questionnaire. If recruitment become a challenge, will target recruitment efforts in primary care 
clinics.  This study may not be able to shed the light on effectiveness specific mechanisms of SAM clinic 
intervention e.g. group component vs sleep provider interaction or more. Further research will be needed to 
investigate it.  
 
Adverse Event Reporting: Reporting of adverse events will follow standard reporting guidelines. Each event 
will be classified according to its severity, whether it was expected or unexpected, and its likelihood of 
relatedness to the study and reviewed by the study medical monitor, Colleen Lance. 
 
Consent: Consent forms will explain in a lay persons' terminology the nature of all procedures. It will be 
stressed that participation is voluntary. The research assistant and PI will be available to answer questions. All 
activities will be compliant with local IRB and HIPPA guidelines, such as obtaining physician permission to 
initiate contact, destroying all pre-screening forms, and obtaining verbal permission, as appropriate for phone 
interviews. At the beginning of the study, and then periodically, any IRB, HIPAA or privacy requirements that 
may be in effect at that time also will be checked to assure that plans are compliant with current rules. 
Once a person has been identified as eligible to participate in the study, written consent and HIPAA 
authorization will be obtained. All hard copies of this health information will be destroyed about all patient who 
do not meet study criteria and those who decline participation. All personal health information collected and 
retained on site prior to obtaining written authorization will be de-linked from identifying personal information. 
Also, if written authorization is not obtained within 90 days of patient who have agreed to participate in the 
study, their health information will be destroyed. 

 
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8/14/2019, Ver3 
 
Potential Benefits: Participants with sub-optimal adherence may benefit from early recognition. Participants 
may also benefit sleep hygiene education to improve over sleep. 
 
Participants will receive a monetary compensation of $50 after completing all necessary study visits at the end 
of 3 months. This payment bay be considered taxable income by the IRS. The participant will be issued a 
1099-Misc form only if payment exceeds $600 from all studies in which they are participating in a fiscal year. 
 
Dissemination Plan: The study will begin in January 2019 (Table 3 shows timeline)  
1. July 2019- complete recruitment of 16 patients in each arm. Manuscript preparation “Rationale for the 
development of randomized controlled trial for sleep apnea management clinic to assess the PAP 
adherence”.  
2. June 2020- cross sectional analyses will be performed to understand the subject characteristics of 
participants, data analyzed will be used to submit abstract (and manuscript preparation) to national SLEEP 
Meeting “Subject characteristics of patients presenting in Sleep apnea management group clinic in a 
randomized controlled trial”  
3. July 2020- complete recruitment 
4. Dec 2020- Analyze final data; we will submit an abstract to the 2021 Annual SLEEP meeting and utilize 
data to prepare multiple publications. Primary manuscript on “Impact of a Novel Sleep Apnea Management 
Group Intervention on Positive Airway Pressure Adherence: A Randomized Controlled Trial”. We estimate 
that there will be ~30% increase in PAP adherence in SAM group compared to usual arm. We also 
estimate significant improvement in PROs.  Secondary manuscripts prepared for peer-reviewed journals 
will focus on Impact of Sleep Apnea Management Group on patient reported outcomes: “Findings from a 
randomized controlled trial and Effectiveness of Sleep Apnea management group clinic on Barriers to 
Continuous positive pressure adherence”.  
 
SIGNIFICANCE OF THIS STUDY: The proposed work provides a high impact opportunity and addresses two 
of the proposed research domains including 1. Assessment of barriers of PAP adherence and 2. PAP 
adherence and PROs managed by sleep providers in a novel group clinic setting of SAM group clinic and 
comparison with a group managed by providers. The data generated from this proposal will provide effect sizes 
necessary to inform multi center randomized clinical services research trials. Such an endeavor to research 
service configuration would be transformative for understanding how PAP treatment can be extended to larger 
populations of patients..  In doing so, this line of investigation will likely have a significant clinical impact to 
enhance PAP adherence and ameliorate adverse clinical outcomes associated with OSA patient populations 
across systems of care. The success of the project will lay in the foundation as a model of effective care 
provided in group clinics in those with addressable issues with PAP adherence. 
 
 
 
Table 3: A Timeline for The Conduct of the Project 
                                             Calendar Year  
2019 
2020 
2021 
                                                 Quarter 
1 
2 
3 
4 
1 
2 
3 
4 1 
2 
Hiring, refining protocol, Personnel training,  
IRB Approval, Establishment of recruitment strategies 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
 
 
 
 
 
Anticipated accrual numbers in each arm 
 
16 
16 
17 
17 
17 
 
 
 
 
Follow up numbers 
 
 
16 
16 
17 
17 
17 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
Abstracts and Manuscript Preparation 
 
 
 
 
 
 
 
 
 
 
Grant Writing  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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8/14/2019, Ver3 
 
SAMPAP Study Timeline (Recruitment to Study Completion) 
Day 0  
- 
Patient initiates PAP 
Week 2 
- 
Initial eligibility check 
- 
Letter sent to referring provider 
Week 3 
- 
Letter/consent sent to patient 
Week 4 
- 
Recheck compliance eligibility 
- 
Eligibility confirmed over phone 
- 
Consent completed over phone 
Week 4-8 (Baseline) 
- 
Signed Consent received 
- 
Randomization 
- 
Schedule SAM clinic visit if necessary 
- 
Baseline REDCap forms completed 
- 
Baseline patient survey sent and returned 
- 
SAM clinic (if randomized as such) 
Week 8-12 (1mo) 
- 
1mo patient survey sent and returned 
Week 16-20 (3mo) 
- 
3mo patient survey sent and returned 
- 
Stipend issued 
 
 
 
References 
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Mehra R. Sleep apnea ABCs: airway, breathing, circulation. Cleve Clin J Med 2014;81:479-89. 
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McEvoy RD, Antic NA, Heeley E, et al. PAP for Prevention of Cardiovascular Events in Obstructive 
Sleep Apnea. N Engl J Med 2016. 
3. 
Weaver TE. Adherence to positive airway pressure therapy. Curr Opin Pulm Med 2006;12:409-13. 
4. 
Likar LL, Panciera TM, Erickson AD, Rounds S. Group education sessions and compliance with nasal 
PAP therapy. Chest 1997;111:1273-7. 
5. 
Lewis KE, Bartle IE, Watkins AJ, Seale L, Ebden P. Simple interventions improve re-attendance when 
treating the sleep apnoea syndrome. Sleep Med 2006;7:241-7. 
6. 
Lettieri CJ, Walter RJ. Impact of group education on continuous positive airway pressure adherence. J 
Clin Sleep Med 2013;9:537-41. 

 
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7. 
Walia HK, Griffith SD, Thompson NR, Moul DE, Foldvary-Schaefer N, Mehra R. Impact of Sleep 
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Patients. J Clin Sleep Med 2016. 
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Breathing Treatment on Quality of Life Measures in a Large Clinic-Based Cohort. J Clin Sleep Med 
2017;13:1255-63. 
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Aurora RN, Collop NA, Jacobowitz O, Thomas SM, Quan SF, Aronsky AJ. Quality measures for the 
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