Improving sleep for individuals with traumatic brain injury
Official title: University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)
Run by VA Eastern Colorado Health Care System · NCT05683145 · Data updated 2026-11-12
This study tests a new online therapy program to help people with moderate to severe traumatic brain injury improve their sleep quality compared to standard treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | VA Eastern Colorado Health Care System Federal |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT05683145 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with a history of moderate to severe TBI who are currently experiencing insomnia.
✕Probably not a fit
Patients with active substance dependence, current psychosis, or other sleep disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a guided computerized cognitive behavioral therapy for insomnia (cCBT-I) against enhanced treatment as usual (ETU) for individuals with moderate to severe traumatic brain injury (TBI). It addresses the high prevalence of insomnia in this population, which significantly impacts recovery and quality of life. The intervention aims to improve sleep quality through cognitive therapy, behavioral techniques, and psychoeducation, while being accessible and low-cost. Participants must have reliable internet access and a history of insomnia following their TBI.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall rehabilitation outcomes for patients with traumatic brain injury.
How similar studies have gone: Previous studies have shown success with cognitive behavioral therapy for insomnia in the general population, but this approach for individuals with moderate to severe TBI is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of post-acute (i.e., at least one year after injury) moderate to severe traumatic brain injury * Current insomnia * Reliable access to the internet * Ability to provide informed consent Exclusion Criteria: * Active substance dependence, excluding cannabis * Current psychosis * Bipolar disorder * Current sleep disorders other than insomnia, including sleep apnea * Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns. * Currently receiving psychological treatment for insomnia * Pregnancy * Currently involved in another research interventional trial targeting insomnia
Where it's running
-
Rocky Mountain Regional VAMC
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Lisa A Brenner, PhD — Rocky Mountain VA Mental Illness, Research, and Education Center
- Study coordinator: Emerald Saldyt
- Email: EMERALD.SALDYT@UCDENVER.EDU
- Phone: 720-723-6554
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing whether online therapy for insomnia or mindfulness techniques can help veterans with brain injuries sleep better and feel less depressed.
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This study is testing whether a nurse-guided treatment for insomnia can help people recovering from brain injuries sleep better and improve their mood and thinking.
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Music therapy after stroke
This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.
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Remote ischemic conditioning for post-stroke insomnia
A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.
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PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury
This study tests whether blood biomarkers, health data from records, and wearables can help predict how people recover after a mild traumatic brain injury treated in the emergency department.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.