Phase 2
N=36
Apnea and Insomnia Relief Study
Sleep Apnea Syndromes · Insomnia Disorder · Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT04007796 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: World Health Organization Quality of Life (WHOQOL-BREF) — 11.26; 9.75; 12.78; 10.84 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Apnea and Insomnia Relief (AIR) (Behavioral); Sleep Education (SE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY World Health Organization Quality of Life (WHOQOL-BREF) |
11.26; 9.75; 12.47; 10.71 | — |
| PRIMARY World Health Organization Quality of Life (WHOQOL-BREF) |
11.26; 9.75; 12.47; 10.71 | — |
| SECONDARY Functional Outcomes of Sleep Questionnaire (FOSQ-10) |
13.22; 11.58; 14.52; 13.50 | — |
| SECONDARY Functional Outcomes of Sleep Questionnaire (FOSQ-10) |
13.22; 11.58; 14.52; 13.50 | — |
| SECONDARY Insomnia Severity Index (ISI) |
19.11; 19.06; 12.47; 14.64 | — |
| SECONDARY Insomnia Severity Index (ISI) |
19.11; 19.06; 12.47; 14.64 | — |
| SECONDARY Total Sleep Time (Actigraphy-based) |
417.43; 373.71; 380.50; 367.82 | — |
| SECONDARY CPAP Adherence |
148.71; 112.67 | — |
| SECONDARY CPAP Adherence |
148.71; 112.67 | — |
| SECONDARY Clinician Administered PTSD Scale for DSM-5 (CAPS-5) |
28.78; 29.19; 19.12; 26.13 | — |
Summary
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04007796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.