Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury

The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual. The investigators will also compare the effectiveness of traditional in-person CBT-I and CBT-I delivered via a clinician-supervised digital health platform, Clinician Operated Assistive Sleep Technology (COAST) in comparison to treatment as usual on symptoms of insomnia, post-concussive symptoms, neurocognitive functioning, and psychological health. Participants will be assessed at baseline, post-treatment, and 3 months later.

NCT Number	NCT06867666
Lead Sponsor	Noctem, LLC Collaborators: Naval Health Research Center, United States Naval Medical Center, San Diego
Conditions	Insomnia, TBI (Traumatic Brain Injury)
Enrollment	168 participants
Start Date	2025-04-01
Primary Completion	2027-01-31 (estimated)
Study Completion	2027-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-24