Improving Sleep Apnea Treatment Adherence After Brain Injury: A Feasibility Study
Phase: NA
Conditions: Sleep Apnea, Obstructive, Brain Injuries, Traumatic
Sponsor: VA Office of Research and Development

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Study Title: 
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Behavioral Intervention to Improve Sleep Apnea Treatment Adherence in Veterans with Traumatic 
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Brain Injury: A Feasibility Study 
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Short Title: 
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Intervention to Improve Sleep Apnea Treatment Adherence 
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USF eIRB Protocol Number: 
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Pro00041471 
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Principal Investigator: 
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Marc A. Silva, PhD 
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Study Site: 
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James A. Haley Veterans’ Hospital, Tampa, FL 
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Sponsor:  
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Not funded 
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1. Rationale for the study, area of current scientific concern and why the research is needed. 
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Sleep Apnea is among the leading sleep disorders in Veterans seeking VA healthcare32 increasing 
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their risk for myriad adverse outcomes including poor physical health,5-6,13-14 impaired cognition, 
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higher risk for dementia,10-12,18 and declining mental health (i.e., worsening posttraumatic stress 
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disorder symptoms,33 suicidal ideation,34 and lack of treatment responsiveness).34  Sleep Apnea is a 
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treatable health condition that commonly co-occurs with Traumatic Brain Injury (TBI), which is a 
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leading cause of long-term disability,36 affecting over 1.7 million individuals annually in the United 
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States,37 and over 380,000 members of the armed forces since the year 2000.38  To date, 
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interventions to improve guideline-endorsed frontline Positive Airway  Pressure (PAP) treatment17 
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for persons with comorbid Sleep Apnea and moderate-to-severe TBI have not been developed 
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despite high PAP nonadherence rates. 21,30   
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This study will develop, test, and refine a clinical intervention designed to enhance PAP adherence 
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with cognitive accommodations for persons with moderate-to-severe TBI.39  Should this 
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intervention prove feasible, results will inform a future trial to determine its efficacy, with 
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subsequent research to include studies on effectiveness, wide-scale adoption, and implementation 
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within the VA. The clinical intervention results will be translatable to other populations with similar 
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neurologic burden (i.e., stroke, anoxia, mild cognitive impairment) and can be adopted by other 
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healthcare systems in the private sector and Department of Defense (DoD). Stakeholder Input: 
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Improving PAP adherence in at-risk populations (e.g., TBI) are high priority research needs identified 
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by national stakeholder-led initiatives led by the Agency for Healthcare Research and Quality 
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(Future Research Needs Project)40 and joint collaboration between the National Institute of Health 
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and Sleep Research Society.41 Further, input by clinicians and Veterans (Tampa Veterans 
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Engagement Council)42 was used in refinement of topic selection, study methodology, and 
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refinement of the manualized intervention to maximize the research translation success.   
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2. Background information, description of existing research and information that is already 
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known. 
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Sleep Problems Are Prevalent in TBI Rehabilitation Settings. In the largest study examining sleep 
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disturbance in acute rehabilitation for moderate-to-severe TBI, we reported 84% of 205 consecutive 
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admissions had sleep disruption of varying severity.27  During a time of critical neural repair, 63% of 
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the sample remained sleep disturbed, 33% with moderate to severe sleep disturbance (i.e., several 
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nighttime awakenings), near the time of rehabilitation discharge.27   
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Sleep Affects Outcomes After Controlling for TBI Injury Severity. After controlling for known 
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predictors of TBI outcomes (age, time elapsed since injury, and initial Glasgow Coma Scale score), 
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we reported that the presence of persistent moderate or severe sleep disturbance predicted longer 
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rehabilitation length of stay, prolonged posttraumatic amnesia (PTA), and lack of improvement on 
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serial cognitive testing.28  The impact of acute sleep-wake cycle disturbance was highlighted by Dr. 
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Silva’s work demonstrating that individuals with greater daytime hypersomnolence cooperated less 
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with rehabilitation therapies.20  These studies demonstrate that post-TBI sleep problems are 
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associated with negative outcomes (i.e., prolonged impaired cognition, decreased benefit from 
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rehabilitation therapy, and higher cost of care).  
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Incidence of Sleep Apnea in TBI. Our group published a study with the largest consecutive series of 
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patients admitted for TBI rehabilitation who underwent diagnostic polysomnography during 
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inpatient rehabilitation to diagnose presence and severity of sleep apnea.2  Thirty-seven percent 
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were diagnosed with sleep apnea, a significantly higher incidence relative to the general 
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population,29 and higher than estimates by recent meta-analytic review in TBI (25%).1   
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Sleep Apnea Treatment Adherence is Poor in Veterans with TBI. Dr. Silva was the first to report on 
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guideline endorsed frontline therapy (PAP)17 among Veterans and Military Service Members 
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hospitalized after moderate or severe TBI and diagnosed with Sleep Apnea. In this study, 68% did 
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not adhere to PAP treatment during a time of critical neural repair.30  Examination of downloadable 
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smart cards revealed that PAP was used 29% of the nights monitored with a median duration of one 
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hour per night.30  This level of PAP usage is far below the recommended adherence guideline of ≥ 4 
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hours per night on at least 70% of nights.5 Compared to the general population, the rate of 
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nonadherence observed was substantially higher in our TBI cohort.21      
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Adherence to PAP is essential to reap the therapeutic benefit of the treatment.22  To date, no 
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studies have examined maximizing frontline PAP treatment for persons with TBI. Therefore, the 
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objective of this study is to develop and test the feasibility of a manualized intervention to 
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maximize PAP success in Veterans with Sleep Apnea and TBI to improve neurologic recovery and 
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maximize long-term outcomes. Existing interventions to improve PAP adherence have not been 
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adapted for persons with TBI. Psychoeducation is part of the standard of care for the treatment of 
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Sleep Apnea17 but on its own has been shown to be ineffective in improving PAP adherence.22-23  
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Alternatives include Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT).  
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Unfortunately, these evidence-based interventions have not yet been adapted to address PAP 
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adherence in persons with TBI, who often require cognitive accommodations.39  Hence, it remains 
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unknown whether these evidence-based interventions (designed for cognitively healthy individuals) 
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are feasible for, and have the ability to improve adherence in, persons with moderate-to-severe TBI.  
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3. The research questions, objectives, and purpose. 
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This is a 2-year mixed methods43 study using quantitative and qualitative inquiry to determine the 
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feasibility and acceptability of a novel 4-session PAP adherence intervention based on evidence-
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based MI and CBT, with cognitive accommodations for TBI (Aim 1). Feasibility is the ease to which 
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the intervention can be delivered (e.g., eligibility rates, recruitment rates), and acceptability is the 
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extent to which persons receiving the intervention consider it appropriate (e.g., satisfaction 
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ratings).44-45  Feasibility of process and outcome measures (e.g., completeness, perceived value and 
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burden)46 will also be examined (Aim 2). We will explore preliminary response to the intervention 
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by examining PAP usage (Aim 3). There are no study hypotheses specified, consistent with 
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recommendations for designing clinical research feasibility studies.47-48,86   
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4. The study design including information that is needed to answer the research questions 
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Prospective, within subjects, repeated measures design. 
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After consent, participants will complete pre-intervention questionnaires. Then, they will receive 
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the manualized intervention. After each session, they will complete a questionnaire on their 
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experience. After all sessions, they will complete post-intervention questionnaires, and participate 
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in an interview about their experience of the intervention. Intervention sessions will be recorded 
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and reviewed for fidelity. Data from questionnaires will be entered into a database for analysis. 
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Interview data will be qualitatively analyzed.  
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5. Sample size 
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19 participants 
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6. Study Population inclusion and exclusion criteria 
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Inclusion criteria: (1) moderate-to-severe TBI consistent with consensus definition;55 (2) diagnosed 
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with sleep apnea; (3) prescribed PAP therapy; (4) nonadherent to PAP treatment;5 and (5) able to 
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consent. 
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7. The expected results of the research, such as reports, papers, and contributions to theory 
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Refinement of the manualized intervention, to be tested in a future RCT 
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Identification of appropriate outcome measures for this intervention 
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Presentations at scientific meetings targeting rehabilitation and military/veteran health care 
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audiences 
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Publication of study results in a scientific, peer-reviewed journal 
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8. Name of the Principal Investigator and Faculty Advisor if applicable 
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Principal Investigator:  Marc A. Silva, PhD 
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Faculty Advisor: 
Not Applicable 
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9. Any potential risks to the subjects 
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The potential risks associated with this study are minimal. The activities and procedures of this 
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study are non-invasive, thus risk of physical harm is unlikely. It is possible that emotional discomfort 
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may occur while participating in the brief cognitive test, or completing symptom questionnaires, or 
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when discussing the participant’s health and sleep apnea treatment. In the event of emotional 
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discomfort, the participant may choose to discontinue the activity. Also, we can notify the 
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participant’s current health care treatment providers or refer the participant to a physician or 
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psychologist if the participant would like us to. We do not anticipate any financial or legal risk 
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associated with this study. It is possible that there risks that are unknown to us. 
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Safety precautions that will be taken to minimize risks/harms: Study staff follow VA hospital policy 
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and complete annual trainings related to HIPAA, Privacy, and Information Security. Hard copy data 
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(data collection forms, recordings of counseling intervention sessions) will be stored in a locked 
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cabinets in locked offices (Bldg 38, Room C-253 and B-258). Data collection forms will not contain 
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name, social security number, or other personal identifiers, with the exception of date of birth 
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which is used to calculate age at various points in time (e.g., at injury, at time of sleep apnea 
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diagnosis, at time of study participation). Recordings will be identified using a unique ID number 
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that will be assigned to each participant for this study – it will not contain name, social security 
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number, or other identifiers. Only members of the research team have access to research data. 
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Electronic data (e.g., Electronic Data Set) will be stored on a secure folder on the VA server, behind 
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the VA firewall, within R:/PROJECTS_CURRENT. The tracking form that links the participant’s 
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identity to the ID number, and will be a in its own document, separate from the Electronic Data Set, 
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which stores data collected as part of this research study. Research records will be maintained 
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according to VA hospital policy.  
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10. Any experimental procedures or interventions that will be implemented 
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The intervention is derived from evidence-based Motivational Interviewing (MI) and Cognitive 
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Behavioral Therapy (CBT), which have been utilized in non-brain injured populations to improve 
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adherence in the context of various behavioral health conditions.17,24-26   
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The intervention is designed as a 4-session treatment. Sessions are generally designed to occur over 
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4 separate visits lasting approximately an hour for each session. The intervention is derived from 
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evidence-based psychological treatments drawn from MI and CBT. In addition to participating in 
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discussion and information exchange, the participants will also be asked to track their PAP usage, 
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report on their sleep apnea related symptoms, and share their ratings on their confidence for, 
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barriers to, and facilitators of behavioral change.  
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Participants will be asked to complete symptom measures pre- and post-intervention.  
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Participants will be asked to participate in a post-intervention qualitative interview to provide 
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feedback on the intervention.  
 
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11. Study visit timeline 
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There are approximately 6 visits which can be completed, at the participant’s preference, over the 
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course of 4-12 weeks, to permit flexibility on the part of participants. Completing questionnaires 
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will take approximately 10-15 minutes. The intervention sessions will last approximately 30 to 60 
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minutes. The interview for participant feedback on intervention acceptability will last approximately 
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30 to 60 minutes. 
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12. Any potential benefits to subjects 
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Direct Benefits: None 
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Societal Benefits: By participating in this study, there is potential that study findings will lead to 
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improvement in the management of sleep apnea in persons with brain injury.  
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13. Human subjects considerations: 
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Inpatient TBI/Polytrauma records, outpatient TBI clinic records, and sleep medicine / respiratory / 
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pulmonary records will be reviewed prior to consent for screening purposes. Information to be 
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gleaned will include those needed to ensure study inclusion criteria (TBI diagnosis, Sleep Apnea 
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Diagnosis, prescribed PAP therapy, capacity to consent), as well as determine upcoming clinic 
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appointments so the potential participant can be approached. Informed consent will be obtained 
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from the participant by the PI or designee (e.g., Project Manager or Research Assistant).  
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Information about study purpose, procedures, risk and benefits will be reviewed. They will be 
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informed that study participation is voluntary and they may withdraw at any time. Those who agree 
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will receive a copy of the informed consent document. The signed version will be stored in a locked 
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filing cabinet in a locked office suite (Bldg 38, Room C-253 or B-258).  
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Cognitive impairment is a common consequence of moderate-to-severe TBI. Participants are given 
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the option to confer with trusted others (e.g., family members, their doctor) prior to and during 
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study participation. Appointment reminders are a necessary cognitive accommodation for persons 
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with brain injury. We will contact them via telephone and/or send reminder appointment letters to 
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the phone and/or address of the participant and/or alternative contacted designated by the 
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participant. Although not specifically targeted, active duty service members who are being treated 
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for TBI at the James A Haley VA Hospital (as part of a Memorandum of Understanding for specialty 
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care between VA and DoD) will be recruited, as they are established patients at the James A Haley 
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VA Hospital at the time of study participation.  
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Participants will be assigned a unique identifier. Participant-specific electronic documents will be 
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named using the participant’s ID number, and stored on a VA server behind the VA firewall. Hard 
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copy data will also be labeled using the participant’s ID number, and stored in locked cabinets in a 
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locked offices (Bldg 38, Room C-253 or B-258).  
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14. Data and safety monitoring plan. 
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Not applicable, as this is a minimal risk study. 
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