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Can a simple home test improve sleep care for Brain-Injured veterans?

NCT ID NCT05665764

Knowledge-focused Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether veterans with traumatic brain injury (TBI) and insomnia can reliably measure their internal body clock at home. Thirty-one veterans wore a wrist device for a week and collected saliva samples to track melatonin levels. The goal was to see if these home methods are practical and accurate enough to guide personalized sleep treatments in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

31 people

The number who actually took part.

Started

Jul 2023

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Potential participants will be all willing and eligible U.S. military Veterans aged 18-64 from the following populations: 1) those seeking outpatient services at the Rocky Mountain Regional Veterans Affairs (VA) Medical Center; and 2) those in existing clinical and research databases (e.g., the Rocky Mountain Mental Illness Research, Education and Clinical Center \[RM MIRECC\] research database).

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Veterans * History of traumatic brain injury * Current insomnia Exclusion Criteria: * Alcohol or substance abuse in the past 12 months * History of psychotic or bipolar disorders * Currently using of beta-blockers or melatonin-related substances (including over-the-counter or herbal products) * Currently participating in a sleep-targeted psychotherapy * Transmeridian travel (i.e., change in at least 2 time zones) in the past month * Shift work (i.e., at least 6 hours between 10 pm and 8 am) in the past 6 months * Currently pregnant or lactating * Current untreated sleep apnea * Lack of access to a home freezer * Blindness * Inability to independently provide informed consent

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic insomnia sleep disorder, initiating and maintaining sleep traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries, traumatic Sleep initiation and maintenance disorders

Contacts and locations

Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.