Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06867666

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

N/A

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

Researchers are evaluating Cognitive Behavioral Therapy for Insomnia (CBT-I) in active-duty sailors who have experienced traumatic brain injury (TBI). The study aims to compare the effects of traditional in-person CBT-I and CBT-I delivered through a digital health platform called Clinician Operated Assistive Sleep Technology (COAST) against usual treatment on symptoms of insomnia, post-concussive effects, psychological health, and brain function. Participants will be assessed before treatment, after treatment, and three months later to understand the therapies' impacts. The study involves three groups: one receiving in-person CBT-I at a TBI clinic or via telehealth, another receiving CBT-I remotely through the COAST digital platform, and a third group receiving treatment as usual without insomnia-specific care. Both CBT-I interventions last six weeks and are delivered by doctoral-level clinicians. Participants in all groups will use the COAST app to complete daily sleep logs and assessments throughout the study. Participants will attend baseline and follow-up appointments where various questionnaires and inventories will be completed to measure insomnia severity, post-concussion symptoms, psychological conditions like PTSD, depression, anxiety, fatigue, and disability. Sleep diaries will be kept daily during the intervention and for one week before the follow-up visit. Medication use and sleep apnea therapy stability will be monitored, and assessments will occur at multiple time points including baseline, mid-treatment, post-treatment, and three months after treatment ends. The total participation duration spans from initial evaluation through the 3-month follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active duty Navy sailors or activated reservist Navy sailors only
  • Diagnosis of chronic insomnia with PSQI score greater than 9
  • Confirmed history of traumatic brain injury
  • Stable on psychotropic and hypnotic medications for at least 8 weeks with no expected changes
  • Stable on continuous positive airway pressure therapy for sleep apnea for at least 90 days, using 4+ hours per night at least 70% of nights
  • Ownership of a smartphone or smart device
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Severe traumatic brain injury
  • Current alcohol or substance use disorder
  • Inability to read or understand English
  • Diagnosis of bipolar disorder, psychosis, or seizure disorder
  • Hypersomnia disorder
  • Working rotating shifts or required to work earlier than 6am

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 weeks

Participants receive 6 weeks of cognitive behavioral therapy for insomnia (CBT-I) either in-person or remotely via a digital platform, led by a doctoral-level clinician.

Weekly visits during the 6-week treatment period

Follow-up

Duration - 3 months post-treatment

Participants are followed up to assess insomnia severity and other health outcomes after completing treatment.

1 follow-up visit at 3 months post-treatment

Trial Site Locations

Total: 1 location

1

Naval Medical Center San Diego

San Diego, California, United States, 92134

Actively Recruiting

Loading map...

Research Team

A

Anne Germain, PhD

A

Anice Byrd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Behavioral treatment of insomnia in active-duty service members with traumatic brain injury: study protocol for a randomized clinical trial.

Anne Germain, Megan Wolfson, Emmanuel Espejo...

https://pubmed.ncbi.nlm.nih.gov/41630034