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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03937713
The ClinicalTrials.gov registry entry for NCT03937713 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which eszopiclone is the first listed.
NCT03937713 reports 0 study locations.
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.
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