Amino acid therapy for improving sleep and cognition in veterans with brain injuries
Supplementation With Amino Acid Rehabilitative Therapy in TBI (SmART-TBI): A Randomized Placebo-Controlled Trial to Improve Sleep
This study is testing whether taking branched chain amino acids can help veterans with mild brain injuries sleep better and think more clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT04603443 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dietary supplementation with branched chain amino acids (BCAA) on sleep disturbances and cognitive dysfunction in veterans who have experienced mild traumatic brain injury (mTBI). The study is designed as a randomized, placebo-controlled, double-blinded trial to assess the feasibility, acceptability, and preliminary efficacy of BCAA supplementation. Participants will be veterans aged 18-65 who report sleep and cognitive issues, and the trial aims to gather data that will inform future larger-scale studies. The ultimate goal is to develop a mechanism-based intervention to improve rehabilitation outcomes for veterans suffering from mTBI.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18-65 who experience sleep disturbances and cognitive dysfunction related to mild traumatic brain injury.
Not a fit: Patients who are currently using branched chain amino acids or those with specific medical conditions like amyotrophic lateral sclerosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve sleep quality and cognitive function in veterans with mTBI, enhancing their overall quality of life.
How similar studies have performed: While this approach is novel in the context of mTBI, previous studies have shown promise in using amino acid supplementation for cognitive and sleep-related issues.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Miranda M Lim, MD PhD — VA Portland Health Care System, Portland, OR
- Study coordinator: Miranda M Lim, MD PhD
- Email: miranda.lim@va.gov
- Phone: (503) 220-8262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.