Enhancing Sleep to Improve Brain-heart Functions in People With Persistent Post-concussion Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Ottawa
- Enrollment
- 70
Study Overview
Brief Summary
This project is designed as a randomized controlled trial (RCT), with an active control group. Sleep and heart rate will be monitored at home for 1 week before and after the intervention. Questionnaires will be completed from home before, during and 8 weeks after the end of the Intervention. The Cognitive Behavioural Therapy for Insomnia, adapted for post-concussed individuals (CBT-pI) and control interventions, will be delivered on a digital online platform over an 8-week period. Participants in the control arm will be offered CBT-pI after the follow-up period. All intervention arms will be delivered as adjuncts to standard clinical care. All other treatments received during the intervention will be documented.
Detailed Description
- Background and Rationale
Up to 50% of individuals who sustain a concussion experience sleep disturbances. Poor sleep has been found predictive of poorer outcomes in post-concussion recovery. In Canada, insomnia constitutes a major burden upon public health. Insomnia not only impairs sleep quality but also exacerbates cognitive, emotional, and physiological post-concussion symptoms, including cardiovascular dysfunctions, such as elevated heart rate and sympathetic overactivation; thus, possibly leading to delayed recovery following a concussion. Furthermore, recent work in chronic insomnia identified increased levels of brain microstructure injury biomarkers previously linked to concussion. These disruptions can potentially interfere with brain-heart functions and delay post-concussion recovery. As such, treating insomnia may result in better post-concussion recovery, which may notably be observable through biomarkers linked to brain-heart health.
Cognitive-Behavioural Therapy treatment for insomnia (CBT-I) is the first line of treatment recommended for chronic primary insomnia sufferers. It combines multipronged strategies involving education and progressive personalized sleep manipulations to address the maladaptive cognitive and behavioural processes contributing to the maintenance of insomnia. Five distinct intervention components - stimulus control, time in bed restriction therapy, psychoeducation about sleep, cognitive therapy, and relaxation training - are included within the CBT-I framework. CBT-I has been found effective to address sleep issues emerging after a concussion, with documented benefits for post-concussion recovery. This may notably operate via the restoration of brain-heart functions since CBT-I enhances brain functions following concussions, may influence autonomic regulation by reducing hyperarousal and sympathetic overactivation, and improves cardiovascular outcomes.
One of the putative mechanisms of action of CBT-I resides in increased deep sleep due to enhanced sleep pressure. Deep sleep is a state characterized by high amplitude low frequency brain activity in the delta frequency range on the electroencephalogram (EEG). Recent discoveries highlight the role of deep sleep in autonomic regulation and healing processes. Post-concussion sleep has been associated with increased deep sleep. One may postulate that higher increases in delta activity driven by CBT-I may be associated with enhanced autonomic functions and post-concussion symptoms recovery.
The investigators recently expanded previous results suggesting that individuals with insomnia have low coherence between brain and heart activity. To the best of our knowledge, research has yet to investigate whether successful insomnia treatment, through CBT-I, restores brain-heart interactions, and how changes in brain, heart, and brain-heart interactions may relate to post-concussion symptoms recovery following CBT-I. 2. Study Objectives
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 18 years and older
- •Experiencing persisting post-concussion symptoms > 4 weeks but no more than 12 months post-injury as measured based on home-made screening questions and the Sport Concussion Assessment Tool (SCAT6)
- •Having a Sleep Condition Indicator score suggestive of insomnia (SCI =/< 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month)
- •Meeting diagnostic criteria for insomnia disorder on the SCID
- •Having a smartphone, tablet or computer and willingness to install a sleep intervention application on it
Exclusion Criteria
- •Having undergone another CBT-I program within the past 6 months
- •Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I.
- •Self-reported substance use disorder (i.e., alcohol, cannabis, or illicit drugs) or =/> monthly use of illicit drugs reported on item-2 of the WHO-ASSIST (except tobacco, alcohol, and cannabis)
- •Body mass index > 45
- •Shift work or rotating shifts within 1 month of study entry
- •Recent travel to a different time zone (leaving 1 week of recovery per time zone difference)
- •Any clinically significant neurological disorder aside from concussion (including seizure disorder)
- •Signs of sleep apnea as reflected by combined profiles on the Sleep Disorders Symptoms Checklist-25 and Epworth Sleepiness Scale
- •Unstable psychotropic medications (need to be on a stable dose for at least 1 month prior to study start)
- •Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires
Arms & Interventions
Cognitive Behavioural Therapy for Insomnia
Four bi-weekly sessions lasting about 30-45 minutes covering all core elements of CBT-I, with some adaptations tailored to better serve people with post-concussion symptoms. For instance, the app design will account for light, sound, and visual field motion sensitivity (e.g. light enlarged text fonts on dark background colors, amber filters, sound processing to lower high pitch tones, minimized scrolling, and slow screen transitions). Also, the traditional psychoeducation module will be supplemented with information about sleep changes following concussion, interactions between sleep and chronic pain, expected course of recovery, the benefits of improving sleep for memory, concentration and mood.
Intervention: CBT-pI (Behavioral)
Placebo
A digital sleep hygiene program will mirror the CBT-I intervention. It will be delivered over the same number/length of bi-weekly sessions using the same digital infrastructure as the CBT-PI program. The content will consist of educational information regarding sleep stages, normal sleep architecture, and healthy sleep practices (e.g., reducing caffeine and alcohol, avoiding exercise and other physical activity just before bed, having a light snack before bed, and keeping the bedroom quiet, and at a comfortable temperature).
Intervention: Sleep Hygiene (Behavioral)
Outcomes
Primary Outcomes
Not specified
Secondary Outcomes
- Changes in executive function, visual and motor abilities(From baseline (week 0) to the last follow-up (week 34))
- Changes in visuospatial and working memory(From baseline (week 0) to the last follow-up (week 34))
- Changes in attention and inhibition(From baseline (week 0) to the last follow-up (week 34))
- Changes in executive function, set-shifting, visual and motor abilities(From baseline (week 0) to the last follow-up (week 34))
Investigators
Rébecca Robillard
Assistant Professor
University of Ottawa