Apnea and Insomnia Relief Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).

Detailed Description
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This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.

Official Title
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Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder

Conditions
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Stress Disorders, Post-Traumatic, Sleep Apnea Syndromes, Insomnia Disorder

Intervention / Treatment
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* Behavioral: Apnea and Insomnia Relief (AIR)
* Behavioral: Sleep Education (SE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder Meet DSM-5 Criteria for Insomnia Disorder Willing to attend all treatment and assessment appointments English literacy and cognition sufficient to participate in treatment and assessment Exclusion Criteria: Psychosis or manic episode in last 5 years Moderate or severe substance use disorder in past 6 months Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator) Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator) Working night shifts or rotating shifts that include night shifts Lack of stable housing Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apnea and Insomnia Relief (AIR)<br>This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia. | Behavioral: Apnea and Insomnia Relief (AIR)<br>* This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.<br>|
| Active Comparator: Sleep Education (SE)<br>This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. | Behavioral: Sleep Education (SE)<br>* This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life (WHOQOL-BREF) | This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain. | Change from baseline to 1 week post-treatment (after 6 weeks) | 
| World Health Organization Quality of Life (WHOQOL-BREF) | This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain. | Change from baseline to 3 months after treatment ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcomes of Sleep Questionnaire (FOSQ-10) | This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning. | Change from baseline to 1 week post-treatment (after 6 weeks) | 
| Functional Outcomes of Sleep Questionnaire (FOSQ-10) | This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning. | Change from baseline to 3 months after treatment ends | 
| Insomnia Severity Index (ISI) | This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity. | Change from baseline to 1 week post-treatment (after 6 weeks) | 
| Insomnia Severity Index (ISI) | This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity. | Change from baseline to 3 months after treatment ends | 
| Total sleep time (actigraphy-based) | An actigraph will be used to determine total sleep time. An actigraph is a validated objective sleep measurement device commonly used outside the laboratory setting to detect movement and infer sleep and wake based on wrist activity. | Change from baseline to 1 week post-treatment (after 6 weeks) | 
| CPAP Adherence | Average daily CPAP use. | Past 7 days, at 1 week after treatment ends | 
| CPAP Adherence | Average daily CPAP use. | Past 7 days, at 3 months after treatment ends | 
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | This 30-item semi-structured interview provides a dimensional and categorical measure of PTSD. The severity score is based on frequency and intensity of PTSD symptoms. Categorically, it determines presence of both lifetime and current PTSD. Current and lifetime PTSD will be assessed at pre-treatment. Only current PTSD will be assessed at post-treatment. This interview also assesses the onset and duration of symptoms, distress, impact of symptoms on functioning (social and occupational), change in symptoms since a previous administration, response validity, and dissociative subtype of PTSD. | Change from baseline to 1 week post-treatment (after 6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Stress Disorders, Post-Traumatic, Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Disorder, Veterans