Using light therapy to improve sleep and brain function in post-concussion patients

Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients With Sleep-Wake Disturbances

This study is testing whether light therapy can help people with post-concussion syndrome improve their sleep and brain function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Meditech Rehabilitation Centre (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05072743 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Photobiomodulation Therapy (PBMT) as a treatment for sleep disturbances and neurocognitive issues in patients suffering from post-concussion syndrome. It targets individuals who have experienced a mild traumatic brain injury (mTBI) and are experiencing persistent sleep problems not related to sleep apnea. The study aims to assess improvements in sleep quality and cognitive function through this innovative therapy. Participants will be monitored for changes in their symptoms over the course of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 who have been diagnosed with mTBI and are experiencing sleep disturbances at least 3 months post-injury.

Not a fit: Patients with sleep disorders primarily related to sleep apnea may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance sleep quality and cognitive function for patients recovering from concussions.

How similar studies have performed: While the use of PBMT is a relatively novel approach, preliminary studies have shown promise in similar applications for other conditions.

Eligibility criteria

Inclusion Criteria:

* Patients between the ages of 18-70 years clinically diagnosed with a mTBI diagnosed between 3 to 24 months from presentation complaining of sleep disturbance.
* Underwent an overnight sleep study PSG within the previous year and diagnosed with a primary sleep disorder and in which there has been symptom development suggesting another co-morbid sleep disorder, or an established diagnosis of a sleep disorder other than a sleep related breathing disorder who have significant symptom progression or non-response to therapy.
* Documentation of a history of a qualifying mTBI within 3 to 24 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria for Post Concussive Syndrome (PCS) require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4.

Exclusion Criteria:

* Any positive cranial findings on imaging studies
* A current diagnosis of neuropsychiatric co-morbidity including severe anxiety (or score of ≥15 on the GAD-7), severe depression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder.
* A family history of neuropsychiatric conditions
* Any additional diagnoses compounding the diagnosis of a mTBI.
* Currently undergoing CBT.
* Currently taking any medication for the purpose of improving sleep including medical and recreational cannabis, barbiturates, benzodiazepines, antidepressants, antihistamines, melatonin or other natural supplements.
* Currently undergoing any alternative or complementary medical procedure, i.e. acupuncture, hypnosis, homeopathy, etc.
* Pregnancy
* Malignant growth in the neck and cranium
* Taking any photosensitizing medication.

Where this trial is running

Toronto, Ontario

• Meditech Rehabilitation Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Alan Lowe, MD — Meditech International
• Study coordinator: Ronaldo Santiago, MD

Conditions: Post-Concussion Syndrome, Sleep Disorder, Photobiomodulation