Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT05683145

University of Colorado - Restoring Efficient Sleep After TBI

Led by VA Eastern Colorado Health Care System · Updated on 2026-02-18

80

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

Sponsors

V

VA Eastern Colorado Health Care System

Lead Sponsor

C

Colorado Traumatic Brain Injury Trust Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

Sleep disturbance is a common condition following traumatic brain injury (TBI) and impairs recovery and quality of life. While efficacious interventions exist many are not accessible to all patients due to a variety of factors (e.g., rurality, access to providers). Further, many of the available treatments have not been validated for individuals with moderate/severe TBI. The proposed study will evaluate a guided computerized version of cognitive behavioral therapy for insomnia (cCBT-I) against enhanced treatment as usual (ETU) in individuals with moderate/severe TBI.

CONDITIONS

Official Title

University of Colorado - Restoring Efficient Sleep After TBI

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of moderate to severe traumatic brain injury at least one year prior to enrollment
  • Current insomnia
  • Reliable access to the internet
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Active substance dependence, excluding cannabis
  • Current psychosis
  • Bipolar disorder
  • Current sleep disorders other than insomnia, including sleep apnea
  • Irregular work schedule, shift work, or life changes interfering with regular sleep patterns
  • Currently receiving psychological treatment for insomnia
  • Pregnancy
  • Participation in another insomnia research trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rocky Mountain Regional VAMC

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

E

Emerald Saldyt

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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