Actively Recruiting
Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
Led by Noctem, LLC · Updated on 2025-04-24
168
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
N
Noctem, LLC
Lead Sponsor
N
Naval Health Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active duty Navy or activated Reservist Navy sailors only
- Diagnosis of chronic insomnia with PSQI score greater than 9 confirmed by study evaluators
- Confirmed history of traumatic brain injury
- Stable on psychotropic and hypnotic medications for at least 8 weeks without planned changes
- Stable on continuous positive airway pressure therapy for sleep apnea for at least 90 days with usage of 4 or more hours per night on at least 70% of nights
- Ownership of a smart device for completing electronic sleep logs and assessments
You will not qualify if you...
- Unable to give informed consent
- Severe traumatic brain injury
- Current alcohol or substance use disorder
- Inability to comprehend or read English
- Serious mental health diagnoses such as bipolar disorder or psychosis, or seizure disorder
- Diagnosed hypersomnia disorder
- Working rotating shifts or required to start work earlier than 6am
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Naval Medical Center San Diego
San Diego, California, United States, 92134
Actively Recruiting
Research Team
A
Anne Germain, PhD
CONTACT
A
Anice Byrd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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