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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Meditech Rehabilitation Centre
Toronto, Ontario, Canada
RECRUITINGStatistically 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 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).
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.
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.
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
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.
Time frame: Baseline, 8 weeks
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).
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
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.
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks