An interventional study of MI and CBT 4-session manualized intervention in Sleep Apnea, Obstructive and Brain Injuries, Traumatic, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
Background: Obstructive sleep apnea (OSA) is a sleep disorder common among Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental and physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces many negative health consequences of the disease. Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is the standard of care for OSA treatment with PAP, but on its own is insufficient for improving adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT) which have been shown to improve PAP adherence in general sleep clinic samples. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA.
Study Aims: Study Aim 1 tested the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 evaluated the feasibility of outcome and process measures.
Method: Veterans were recruited from inpatient and outpatient TBI and sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe TBI; nonadherent to PAP, able to provide informed consent) were invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention.
Obstructive sleep apnea (OSA) is condition. The frontline treatment is Positive Airway Pressure (PAP) therapy. Adherence to PAP is essential to reap the therapeutic benefit of the treatment. Psychoeducation is part of the standard of care for the treatment of OSA, but on its own has been shown to be ineffective in improving PAP adherence. In persons without brain injury, alternatives to standard education, such as Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), have been shown to improve PAP adherence. To date, no published studies have examined maximizing frontline PAP treatment for persons with brain injury. Therefore, the objective of this study is to develop and test the feasibility of a manualized intervention, derived from evidence-based MI and CBT, and adapted with cognitive accommodations, to maximize PAP success in Veterans with OSA and TBI-related burden.
This is a 2-year mixed methods study using quantitative and qualitative inquiry to determine the feasibility and acceptability of a novel 4-session PAP adherence intervention (Aim 1). Feasibility is the ease to which the intervention can be delivered (e.g., eligibility rates, recruitment rates), and acceptability is the extent to which persons receiving the intervention consider it appropriate (e.g., satisfaction ratings). Feasibility of process and the ultimate outcome measures (e.g., completeness, perceived value and burden) will also be examined (Aim 2).
Participants will be recruited from clinics within the James A. Haley Veterans' Hospital (JAHVH), a tertiary care facility and teaching hospital. Participants will be recruited from three clinical settings: (1) inpatient TBI neurorehabilitation; (2) outpatient TBI clinics; and (3) sleep medicine clinic. Inclusion criteria for this study are as follows: (1) moderate-to-severe TBI; (2) diagnosed with OSA and prescribed PAP therapy; (3) are nonadherent to PAP treatment; and (4) able to consent. The plan is to enroll 19 participants, because -- using a conservative 75% retention estimate - it is expected that 14 will complete the intervention, exceeding the minimum for data saturation.
Upon receipt of consent, the pre-intervention study measures will be administered. Veterans will be scheduled for four treatment sessions. After the final session, participants will complete post-intervention measures. The intervention will be delivered by a doctoral level psychologist. Two independent evaluators will listen to 20% of audio-recorded sessions and conduct intervention fidelity checks using a Fidelity Rating Checklist created for this study by the PI, and adapted from other rating MI and CBT fidelity forms. Of the recordings, 10% will be the same session to conduct interrater reliability checks of the ratings. Participants will be contacted within 15 business days of their last intervention session for the qualitative interview to gather information on acceptability of the intervention. The project manager/research assistant will download objective PAP adherence data from the PAP software program during study pre-screening and 30 days following the last intervention session, to permit evaluation of adherence.
Analysis will include examination of persons enrolled and retained versus study eligible, and reasons for non-enrollment. Attendance will be described. Acceptability will be examined via the post-intervention interview. Identification of themes will be generated from the analysis using a constant comparative approach. The qualitative team will independently read the data, assign labels and codes to data segments, and develop initial themes, then meet to develop consensus on initial themes and codes, revising them using an iterative process, confirming evidence and consider rival explanations that contrast with findings and conclusions. Study measures. Pre- and post-intervention measures which will be examined for completeness. Descriptive data will be presented (e.g., central tendency, variability, change scores, and effect sizes).
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 17 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Behavioral: MI and CBT 4-session manualized intervention
This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview)
The Narrative Evaluation of Intervention Interview is a 16-item semi-structured interview that elicits participant feedback about an intervention. The data yielded by the NEII are qualitative, using qualitative thematic analysis. All 13 participants who completed the study also completed the NEII interview.
Time frame: Post-intervention (up to 8 weeks after completion of the single arm intervention)
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is an 8-item validated measure of daytime sleepiness. Respondents rate how likely they are to doze in eight situations, each on a scale from 0 to 3. Scores range from 0 to 24. Higher scores representing greater levels of excessive sleepiness
Time frame: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item measure that is sensitive to change following OSA treatment. Respondents rate (on a scale from 1 to 7) the degree of fatigue symptoms experienced within the past 7 days. Total scores range from 9 to 63. Higher scores denote worse fatigue.
Time frame: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Functional Outcomes of Sleep Questionnaire
The Functional Outcomes of Sleep Questionnaire is a 30-item instrument that measures the impact of excessive sleepiness on quality of life in five domains. Items are rated from 1 to 4. Scores range from 1 to 120. Lower scores denote greater impact on quality of life.
Time frame: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Participants were recruited from inpatient TBI units and outpatient TBI clinics per IRB-approved protocol. The recruitment period occurred between August 2020 and December 2021.
| Milestone | Intervention (Single Arm) |
|---|---|
| Started | 17 |
| Completed | 13 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 4 |
The Narrative Evaluation of Intervention Interview is a 16-item semi-structured interview that elicits participant feedback about an intervention. The data yielded by the NEII are qualitative, using qualitative thematic analysis. All 13 participants who completed the study also completed the NEII interview.
| Themes | Intervention (Single Arm) |
|---|---|
| Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview) | 4 |
The Epworth Sleepiness Scale is an 8-item validated measure of daytime sleepiness. Respondents rate how likely they are to doze in eight situations, each on a scale from 0 to 3. Scores range from 0 to 24. Higher scores representing greater levels of excessive sleepiness
| units on a scale | Intervention (Single Arm) |
|---|---|
| Epworth Sleepiness Scale | 11.0 ± 5.0 |
The Fatigue Severity Scale is a 9-item measure that is sensitive to change following OSA treatment. Respondents rate (on a scale from 1 to 7) the degree of fatigue symptoms experienced within the past 7 days. Total scores range from 9 to 63. Higher scores denote worse fatigue.
| units on a scale | Intervention (Single Arm) |
|---|---|
| Fatigue Severity Scale | 36.4 ± 15.6 |
The Functional Outcomes of Sleep Questionnaire is a 30-item instrument that measures the impact of excessive sleepiness on quality of life in five domains. Items are rated from 1 to 4. Scores range from 1 to 120. Lower scores denote greater impact on quality of life.
| units on a scale | Intervention (Single Arm) |
|---|---|
| Functional Outcomes of Sleep Questionnaire | 14.7 ± 3.7 |
Collected over Adverse events time frame was between August 2020 (starting enrollment) until June 2022 (end of study). For each participant, adverse events monitoring occurred between time of study enrollment and either (1) time completed all study procedures, or (2) time participant withdrew from study. The adverse event monitoring period lasted for 1 year and 10 months. For the study sample as a whole, the average monitoring period was 139.6 days (or an average of 20 weeks or 4.6 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention (Single Arm) | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(Years) | Intervention (Single Arm) |
|---|---|
| Mean | 53.2 ± 11.8 |
| Sex: Female, Male(Participants) | Intervention (Single Arm) |
|---|---|
| Female | 0 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Intervention (Single Arm) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Intervention (Single Arm) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | Intervention (Single Arm) |
|---|---|
| United States | 17 |
| Apnea-Hypopnea Index (AHI)(Events per hour) | Intervention (Single Arm) |
|---|---|
| Mean | 22.9 ± 28.2 |
| Oxygenation Nadir(% peripheral oxygen saturation) | Intervention (Single Arm) |
|---|---|
| Mean | 86.0 ± 3.8 |
| Glasgow Outcome Scale-Extended (GOS-E)(units on a scale) | Intervention (Single Arm) |
|---|---|
| Mean | 5.2 ± 1.4 |
7 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Supporting information: Study protocol, Icf
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