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NCT05683145 · ClinicalTrials.gov registry record · NA

University of Colorado - Restoring Efficient Sleep After TBI

A NA study of Traumatic Brain Injury and Insomnia, sponsored by VA Eastern Colorado Health Care System.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT05683145: Recruiting NA study of Traumatic Brain Injury and Insomnia, sponsored by VA Eastern Colorado Health Care System.

NCT05683145 is a NA study of Traumatic Brain Injury and Insomnia that is actively recruiting participants, run by VA Eastern Colorado Health Care System. The registered enrollment target is 80 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05683145, a NA study of Traumatic Brain Injury and Insomnia, is actively recruiting participants, sponsored by VA Eastern Colorado Health Care System.

RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

The change in the total score of the ISI, compared across study arms, will be used as the outcome.

Interventions

  • BEHAVIORAL Computerized Cognitive Behavioral Therapy for Insomnia

Study Locations (1)

Colorado

  • Rocky Mountain Regional VAMC - Aurora

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-07-01
Est. Completion 2026-05-01
Phase NA

What NCT05683145 shows while recruiting

NCT05683145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (71% lower).

The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Computerized Cognitive Behavioral Therapy for Insomnia is the first listed.

NCT05683145 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT05683145 about?

NCT05683145 is a clinical study titled "University of Colorado - Restoring Efficient Sleep After TBI". 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 tre...

What is the current status of trial NCT05683145?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-07-01. Estimated completion is 2026-05-01.

What conditions does trial NCT05683145 study?

This clinical trial studies the following conditions: Traumatic Brain Injury, Insomnia.

What interventions are being tested in trial NCT05683145?

The interventions under investigation include: Computerized Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL).

Who is sponsoring clinical trial NCT05683145?

This trial is sponsored by VA Eastern Colorado Health Care System, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05683145 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Traumatic Brain Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05683145's enrollment target sits among peer trials

80 86th of 171 higher than 85 of 171 other Traumatic Brain Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05683145, the US trial registry maintained by the National Library of Medicine. NCT05683145 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.