Post-Concussion SyndromeNCT05072743
Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients
A study testing Photobiomodulation Therapy in people with Post-Concussion Syndrome and Sleep Disorder, run by Michael Zitney at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Concussion Syndrome, Sleep Disorder
- What is being tested?
- Photobiomodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Meditech Rehabilitation Centre
Toronto, Ontario, M8W 4W3
Ronaldo Santiago, MD, 4162511055, ronaldo@bioflexlaser.com
Michael Zitney, MD
About this study
Official title: Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients With Sleep-Wake Disturbances
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.
Read the detailed description
Concussion or mild traumatic brain injury (mTBI) is an acute neurophysiological event related to blunt impact applied to the head and/or neck due to sudden acceleration, deceleration or rotational forces. It can happen due to motor vehicle accidents, sport or recreational injury, falls, workplace injury or assault. mTBI can be differentiated from moderate and severe traumatic brain injuries by having negative imaging or laboratory results and a Glasgow Coma Scale (GCS) score of 13-15. Current treatment modalities for the various symptoms associated with mTBI are mostly supportive: pain medication, antidepressants, psychotherapy, physiotherapy, vision therapy and referral to sleep clinics.
mTBI symptoms are usually divided into four groups: cognitive symptoms, physical symptoms, emotional symptoms and sleep symptoms. Although most of these symptoms resolve or improve with or without treatment within 3 months following injury there is a significant population of post-mTBI patients who continue to suffer from symptoms 3 months to years after their injury. Previously called Post-Concussive Syndrome (PCS) most groups now classify PCS as a neurological disorder with persistent post-concussive symptoms. Insufficient and disturbed sleep are reported by half of all patients and are among the most common complaints following mTBI, and can develop during the early to chronic post-mTBI phases. Various sleep abnormalities, including post-TBI insomnia, hypersomnia, and sleep apnea are frequently observed. Most cases of sleep symptoms associated with mTBI that are diagnosed during sleep studies tend to be apnea related, although the cause of this is still unknown. Sleep apnea can be obstructive or central sleep apnea, but both types tend to respond well to Continuous Positive Airway Pressure. For other types of non-apneic sleep related symptoms post mTBI though, treatment can vary from Cognitive Behavioural Therapy (CBT) to various sleep medications. However, it is noted that despite an improvement in objective sleep symptoms with conventional approaches to patients with mTBI, there continues to be a lack of improvement in terms of subjective sleepiness or neuropsychological functions.
Photobiomodulation therapy (PBMT) is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders, including concussions. Noted among the effects of PBMT among post-mTBI patients in our clinic is a subjective improvement in sleep, sometimes described by patients as "the best sleep they've ever had." Our 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 their sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.
- Conditions
- Post-Concussion Syndrome, Sleep Disorder
- Being tested
- Photobiomodulation Therapy
- Keywords
- Post-Concussion Syndrome, Photobiomodulation, Sleep Disorder
- Medical subject headings
- Post-Concussion Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyDevice
Also called Low Level Laser 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.
| Study group | Role | What they receive |
|---|---|---|
| Post-Concussion Patients with Non-Apneic Sleep Disorder | Experimental | 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. Receives: Device: Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 4 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: Baseline, 4 weeks
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 8 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: Baseline, 8 weeks
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 12 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: Baseline, 12 weeks
Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 4 weeks
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Baseline, 4 weeks
Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 8 weeks
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Baseline, 8 weeks
Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 12 weeks
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: 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.
Overnight measurement of sleep stage duration in minutes utilizing 3 studies: electroencephalography (EEG), electrooculography (EOG), and surface electromyography (EMG). Other parameters that may also be monitored to measure sleep stage duration include the following: Electrocardiography, Pulse oximetry, Respiratory effort (thoracic and abdominal), End tidal or transcutaneous Carbon Dioxide (CO2), Sound recordings to measure snoring, Surface EMG monitoring of limb muscles (to detect limb movements, periodic or other). These studies are consolidated by a sleep physician to determine and identify each sleep stage in minutes. Only data regarding the duration in minutes as identified by the sleep physician will be collected.
Measured: 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
Overnight measurement of sleep stage duration in minutes utilizing 3 studies: electroencephalography (EEG), electrooculography (EOG), and surface electromyography (EMG). Other parameters that may also be monitored to measure sleep stage duration include the following: Electrocardiography, Pulse oximetry, Respiratory effort (thoracic and abdominal), End tidal or transcutaneous Carbon Dioxide (CO2), Sound recordings to measure snoring, Surface EMG monitoring of limb muscles (to detect limb movements, periodic or other). These studies are consolidated by a sleep physician to determine and identify each sleep stage in minutes. Only data regarding the duration in minutes as identified by the sleep physician will be collected.
Measured: Baseline, 8 weeks
Secondary outcomes (3)
Statistically significant changes in the Functional Outcomes of Sleep Questionnaire (short version) (FOSQ-10) scores from baseline
The short 10-item version of the original 30 item FOSQ using selected items from each subscale and providing the same definition of sleepy and tired. Items for the FOSQ-10 are distributed among the same subscales as follows: 1) activity level (3 items), 2) vigilance (3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Statistically significant changes in the Motivation and Energy Inventory Short Form (MEI-SF) scores from baseline
The MEI-SF is AN 18-item scale created to assess fatigue and lassitude. The scale was initially developed for the purpose of evaluating interventions to improve motivation and energy in patients with depression, though with further evaluation, its clinical applications could be extended to other patient groups. The MEI assesses three factors: mental or cognitive energy, social motivation, and physical energy.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Statistically significant changes in the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) scores from baseline
RPQ is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury (TBI). It is a 16-item self-report questionnaire that assesses the severity of 16 different PCS symptoms that typically follow TBI. Patients are asked to rate their symptoms before and after their injury and also to rate the severity of their symptoms in the last 24 h. Items follow a 5-point ordinal rating system where 0 = never experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, and 4 = a severe problem. Thus total scores using the sum of all items can theoretically range from 0 to 64.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start20 Oct 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Zitney
- Sponsor type
- University, hospital or other
- Collaborators
- Meditech Rehabilitation Centre
- Responsible party
- Sponsor-investigator, Michael Zitney, Meditech Rehabilitation Centre
- Investigators
- Alan Lowe, MD, Principal investigator, Meditech InternationalMichael Zitney, MD, Principal investigator, MediTech International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072743
- Sponsor's protocol ID
- BFX2
- Status last verified
- Aug 2023
- First submitted
- 17 Sep 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tator CH. Concussions and their consequences: current diagnosis, management and prevention. CMAJ. 2013 Aug 6;185(11):975-9. doi: 10.1503/cmaj.120039. Epub 2013 Jul 22. No abstract available.
PubMed 23877672Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
PubMed 26954410Ruff RM. Mild traumatic brain injury and neural recovery: rethinking the debate. NeuroRehabilitation. 2011;28(3):167-80. doi: 10.3233/NRE-2011-0646.
PubMed 21558623Mathias JL, Alvaro PK. Prevalence of sleep disturbances, disorders, and problems following traumatic brain injury: a meta-analysis. Sleep Med. 2012 Aug;13(7):898-905. doi: 10.1016/j.sleep.2012.04.006. Epub 2012 Jun 15.
PubMed 22705246Schreiber S, Barkai G, Gur-Hartman T, Peles E, Tov N, Dolberg OT, Pick CG. Long-lasting sleep patterns of adult patients with minor traumatic brain injury (mTBI) and non-mTBI subjects. Sleep Med. 2008 Jul;9(5):481-7. doi: 10.1016/j.sleep.2007.04.014. Epub 2007 Jul 16.
PubMed 17638592Castriotta RJ, Atanasov S, Wilde MC, Masel BE, Lai JM, Kuna ST. Treatment of sleep disorders after traumatic brain injury. J Clin Sleep Med. 2009 Apr 15;5(2):137-44.
PubMed 19968047Salehpour F, Mahmoudi J, Kamari F, Sadigh-Eteghad S, Rasta SH, Hamblin MR. Brain Photobiomodulation Therapy: a Narrative Review. Mol Neurobiol. 2018 Aug;55(8):6601-6636. doi: 10.1007/s12035-017-0852-4. Epub 2018 Jan 11.
PubMed 29327206Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.
PubMed 19639754Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
PubMed 7636775King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
PubMed 8551320
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients With Sleep-Wake Disturbances
- ClinicalTrials.gov ID
- NCT05072743
- Acronym / sponsor ID
- BFX2
- Conditions
- Post-Concussion Syndrome, Sleep Disorder
- Keywords
- Post-Concussion Syndrome, Photobiomodulation, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michael ZitneyUniversity, hospital or other
- Collaborators
- Meditech Rehabilitation Centre
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Concussion or mild traumatic brain injury (mTBI) is an acute neurophysiological event related to blunt impact applied to the head and/or neck due to sudden acceleration, deceleration or rotational forces. It can happen due to motor vehicle accidents, sport or recreational injury, falls, workplace injury or assault. mTBI can be differentiated from moderate and severe traumatic brain injuries by having negative imaging or laboratory results and a Glasgow Coma Scale (GCS) score of 13-15. Current treatment modalities for the various symptoms associated with mTBI are mostly supportive: pain medication, antidepressants, psychotherapy, physiotherapy, vision therapy and referral to sleep clinics.
mTBI symptoms are usually divided into four groups: cognitive symptoms, physical symptoms, emotional symptoms and sleep symptoms. Although most of these symptoms resolve or improve with or without treatment within 3 months following injury there is a significant population of post-mTBI patients who continue to suffer from symptoms 3 months to years after their injury. Previously called Post-Concussive Syndrome (PCS) most groups now classify PCS as a neurological disorder with persistent post-concussive symptoms. Insufficient and disturbed sleep are reported by half of all patients and are among the most common complaints following mTBI, and can develop during the early to chronic post-mTBI phases. Various sleep abnormalities, including post-TBI insomnia, hypersomnia, and sleep apnea are frequently observed. Most cases of sleep symptoms associated with mTBI that are diagnosed during sleep studies tend to be apnea related, although the cause of this is still unknown. Sleep apnea can be obstructive or central sleep apnea, but both types tend to respond well to Continuous Positive Airway Pressure. For other types of non-apneic sleep related symptoms post mTBI though, treatment can vary from Cognitive Behavioural Therapy (CBT) to various sleep medications. However, it is noted that despite an improvement in objective sleep symptoms with conventional approaches to patients with mTBI, there continues to be a lack of improvement in terms of subjective sleepiness or neuropsychological functions.
Photobiomodulation therapy (PBMT) is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders, including concussions. Noted among the effects of PBMT among post-mTBI patients in our clinic is a subjective improvement in sleep, sometimes described by patients as "the best sleep they've ever had." Our 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 their sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Concussion Patients with Non-Apneic Sleep Disorder | Experimental | Device: Photobiomodulation TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation TherapyAlso: Low Level Laser TherapyPBMT 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. | Device | Post-Concussion Patients with Non-Apneic Sleep Disorder |
Primary outcome
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 4 weeks
Time frame: Baseline, 4 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 8 weeks
Time frame: Baseline, 8 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 12 weeks
Time frame: Baseline, 12 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 4 weeks
Time frame: Baseline, 4 weeks
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 8 weeks
Time frame: Baseline, 8 weeks
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Statistically significant changes in the Insomnia Severity Index (ISI) scores from baseline and at 12 weeks
Time frame: Baseline, 12 weeks
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
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
Overnight measurement of sleep stage duration in minutes utilizing 3 studies: electroencephalography (EEG), electrooculography (EOG), and surface electromyography (EMG). Other parameters that may also be monitored to measure sleep stage duration include the following: Electrocardiography, Pulse oximetry, Respiratory effort (thoracic and abdominal), End tidal or transcutaneous Carbon Dioxide (CO2), Sound recordings to measure snoring, Surface EMG monitoring of limb muscles (to detect limb movements, periodic or other). These studies are consolidated by a sleep physician to determine and identify each sleep stage in minutes. Only data regarding the duration in minutes as identified by the sleep physician will be collected.
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
Overnight measurement of sleep stage duration in minutes utilizing 3 studies: electroencephalography (EEG), electrooculography (EOG), and surface electromyography (EMG). Other parameters that may also be monitored to measure sleep stage duration include the following: Electrocardiography, Pulse oximetry, Respiratory effort (thoracic and abdominal), End tidal or transcutaneous Carbon Dioxide (CO2), Sound recordings to measure snoring, Surface EMG monitoring of limb muscles (to detect limb movements, periodic or other). These studies are consolidated by a sleep physician to determine and identify each sleep stage in minutes. Only data regarding the duration in minutes as identified by the sleep physician will be collected.
3 secondary outcomes
Statistically significant changes in the Functional Outcomes of Sleep Questionnaire (short version) (FOSQ-10) scores from baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Statistically significant changes in the Motivation and Energy Inventory Short Form (MEI-SF) scores from baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Statistically significant changes in the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) scores from baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 23877672Tator CH. Concussions and their consequences: current diagnosis, management and prevention. CMAJ. 2013 Aug 6;185(11):975-9. doi: 10.1503/cmaj.120039. Epub 2013 Jul 22. No abstract available.
- Background: PubMed 26954410Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
- Background: PubMed 21558623Ruff RM. Mild traumatic brain injury and neural recovery: rethinking the debate. NeuroRehabilitation. 2011;28(3):167-80. doi: 10.3233/NRE-2011-0646.
- Background: PubMed 22705246Mathias JL, Alvaro PK. Prevalence of sleep disturbances, disorders, and problems following traumatic brain injury: a meta-analysis. Sleep Med. 2012 Aug;13(7):898-905. doi: 10.1016/j.sleep.2012.04.006. Epub 2012 Jun 15.
- Background: PubMed 17638592Schreiber S, Barkai G, Gur-Hartman T, Peles E, Tov N, Dolberg OT, Pick CG. Long-lasting sleep patterns of adult patients with minor traumatic brain injury (mTBI) and non-mTBI subjects. Sleep Med. 2008 Jul;9(5):481-7. doi: 10.1016/j.sleep.2007.04.014. Epub 2007 Jul 16.
- Background: PubMed 19968047Castriotta RJ, Atanasov S, Wilde MC, Masel BE, Lai JM, Kuna ST. Treatment of sleep disorders after traumatic brain injury. J Clin Sleep Med. 2009 Apr 15;5(2):137-44.
- Background: PubMed 29327206Salehpour F, Mahmoudi J, Kamari F, Sadigh-Eteghad S, Rasta SH, Hamblin MR. Brain Photobiomodulation Therapy: a Narrative Review. Mol Neurobiol. 2018 Aug;55(8):6601-6636. doi: 10.1007/s12035-017-0852-4. Epub 2018 Jan 11.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 19639754Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.
- Background: PubMed 7636775Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
- Background: PubMed 8551320King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Lowe, MD principal investigator
Meditech International
Michael Zitney, MD principal investigator
MediTech International Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy in people with Post-Concussion Syndrome and Sleep Disorder, run by Michael Zitney at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronaldo Santiago, MD (4162511055 ext. 132, ronaldo@bioflexlaser.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 4 weeks (time frame: Baseline, 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072743, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.