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Can a simple supplement fix sleep after a concussion?

NCT ID NCT04603443

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether taking branched-chain amino acids (BCAAs) can improve sleep and thinking in veterans who have had a mild traumatic brain injury. 160 veterans were randomly assigned to receive different doses of BCAAs or a placebo for 12 weeks. The main goal was to see if the study procedures were practical and if veterans would stick with the treatment, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Branched-chain amino acids (BCAAs)
What this could lead to
If it works, this could point toward a simple dietary supplement to help veterans with mild TBI sleep better and think more clearly.
What could go wrong
This was a small, early-stage trial focused on feasibility, not proof of effectiveness. The results may not show clear benefits, and side effects like stomach upset are possible.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

160 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 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.

Ages

18 to 65 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: * Be Veterans (male and female; any race; 18-65 years of age) * Be English speaking * Be accessible via phone * Be non-decisionally impaired * Attest to there being no chance of being or becoming pregnant during the study (if female) * Attest to no history of maple syrup urine disease or known family history of maple urine syrup disease * Have either a history of self-reported sleep disturbances, either as determined via the Insomnia Severity Index, Functional Outcomes of Sleep Questionnaire or Epworth Sleepiness Scale, clinical assessment, and/or a history of self-reported cognitive disturbance (e.g., poor memory, concentration, attention) * Not have an allergy to sucralose * Not be a shift worker (e.g. have worked night or rotating shifts more than twice in the past month) * Not have a diagnosis of amyotrophic lateral sclerosis * Not be currently supplementing their diet with branched chain amino acids * Not be starting another sleep intervention (e.g., positive airway pressure therapy for sleep apnea, sedative-hypnotic medication, or cognitive behavioral therapy for insomnia) during the study * if already engaged in another sleep intervention, this must be stable and not undergo further changes during the study * Meet diagnostic criteria for TBI using a validated clinical interview Exclusion Criteria: * Pregnancy or female trying to conceive * Under 18 years old * Known history of maple syrup urine disease * Dementia

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

Contacts and locations

Locations

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964, United States

More trials for these conditions

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