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

Sleep Disorder | Post-Concussion Syndrome

The emphasis on this study is to review the use of PBMT as a potential treatment modality to improve both sleep symptoms and consequent neuropsychological functions affected by sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 to 70

Participation 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.

Study Location

Meditech Rehabilitation Centre
Meditech Rehabilitation Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Ronaldo Santiago, MD

[email protected]
4162511055
Study Sponsored By
Meditech Rehabilitation Centre
Participants Required
More Information
Study ID: NCT05072743