Recruiting

Photobiomodulation

Sponsor:

Michael Zitney

Code:

NCT05072743

Conditions

Post-Concussion Syndrome

Sleep Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Photobiomodulation Therapy

Study Details

Brief 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.

Conditions

Post-Concussion Syndrome

Sleep Disorder

Study ID

NCT05072743

Start date

Oct 20, 2021

Status verified date

Aug, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Photobiomodulation Therapy

PBMT will be applied to the cervical spine 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.

Primary outcome measure

  • Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 4 weeks [ Time Frame: Baseline, 4 weeks ]
  • Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  • Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 4 weeks [ Time Frame: Baseline, 4 weeks ]
  • Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  • Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Statistically significant changes in the total duration (in total minutes) of Stage 3 Non Rapid Eye Movement (NREM) or N3 sleep during Type 1 overnight Polysomnography (OSG) from Baseline and at 8 weeks. [ Time Frame: Baseline, 8 weeks ]
  • Statistically significant changes in the total duration (in total minutes) of Stage 4 Rapid Eye Movement (REM) sleep during Type 1 overnight Polysomnography (OSG) from Baseline and at 8 weeks [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Ronaldo Santiago, MD

4162511055ronaldo@bioflexlaser.com

Locations

Meditech Rehabilitation Centre

Recruiting

Toronto, Ontario, Canada, M8W 4W3

Contacts

Ronaldo Santiago, MD

4162511055ronaldo@bioflexlaser.com

Principal Investigator:

Michael Zitney, MD

More Information

Sponsor

Michael Zitney

Last update posted

Aug 30, 2023

Last verified

Aug, 2023

Keywords

  • Post-Concussion Syndrome
  • Photobiomodulation
  • Sleep Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael Zitney on 2023-08-30.