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

Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Canada
Meditech Rehabilitation Centre
RECRUITING
Toronto
Contact Information
Primary
Ronaldo Santiago, MD
ronaldo@bioflexlaser.com
4162511055
Time Frame
Start Date: 2021-10-20
Completion Date: 2024-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Post-Concussion Patients with Non-Apneic Sleep Disorder
Patients will be treated with PBMT using the BIOFLEX® DUO+ system that utilizes a Light Emitting Diode (LED) array pad followed by laser probes. Both delivery methods will be applied to the cervical spine and will entail the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided twice per week for 6 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for the treatment of the cervical spine soft tissue injuries.
Related Therapeutic Areas
Sponsors
Leads: Michael Zitney
Collaborators: Meditech Rehabilitation Centre

This content was sourced from clinicaltrials.gov