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NCT03937713 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD
A Phase 4 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT03937713: Completed Phase 4 study, sponsored by VA Office of Research and Development.
NCT03937713 is a Phase 4 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03937713, a Phase 4 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure (CPAP) is the most effective therapy but adherence to treatment is suboptimal. Insomnia is considered a barrier to long-term adherence. The overarching theme of the proposal is to compare the effectiveness of cognitive behavioral therapy for insomnia (CBT) plus eszopiclone, a nonbenzodiazepine hypnotic, versus CBT alone in Veterans with PTSD who are diagnosed with both OSA and insomnia, using a randomized, clinical trial, on sleep quality of life, PTSD severity, and CPAP adherence.
Primary Outcome
The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire, assessed various aspects of sleep, sleep quality, and sleep disturbances. The PSQI is composed of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score. An overall score ranges from 0 to 21, where lower scores denote a healthier sleep quality.
Interventions
- DRUG eszopiclone
- BEHAVIORAL Brief behavioral therapy for insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2025-03-30 |
| Phase | Phase 4 |
What the finished NCT03937713 record still lists
NCT03937713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which eszopiclone is the first listed.
NCT03937713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03937713 about?
NCT03937713 is a clinical study titled "Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD". Obstructive sleep apnea (OSA) is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure (CPAP) is the most effective therapy but adherence to treatment is ...
What is the current status of trial NCT03937713?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2019-12-01. Estimated completion is 2025-03-30.
What interventions are being tested in trial NCT03937713?
The interventions under investigation include: eszopiclone (DRUG), Brief behavioral therapy for insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT03937713?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03937713's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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