Trials / Completed
CompletedNCT04007796
Apnea and Insomnia Relief Study
Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- VA Office of Research and Development · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Apnea and Insomnia Relief (AIR) | 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 | Sleep Education (SE) | 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. |
Timeline
- Start date
- 2020-02-27
- Primary completion
- 2024-10-31
- Completion
- 2025-02-17
- First posted
- 2019-07-05
- Last updated
- 2026-03-12
- Results posted
- 2025-12-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04007796. Inclusion in this directory is not an endorsement.