drugset / Trial / NCT03937713

Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD

NCT03937713

Phase 4 Completed 53 enrolled VA Office of Research and Development
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-12-01
Primary completion
2024-09-30
Completion
2025-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Eszopiclone Small molecule 2 mg Oral

Indications