Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
Purpose
Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.
Conditions
- Concussion (Diagnosis)
- Concussion, Mild Traumatic Brain Injury
- Treatment
- Sleep Health
- Depression, Anxiety
Eligibility
- Eligible Ages
- Between 10 Years and 19 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory [PCSI] score ≥9) - Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria - 10-19 years of age (aligned with World Health Organization definition of 'adolescent')
Exclusion Criteria
- History of treatment for pre-concussion sleep-related disorders
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The study will use a block stratified randomized clinical trial design. Our strata factor are the biological variable of sex and form of assessment (remote vs. in-person)
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- The study principal investigator (PI) and the biostatistician will not know group assignments until after the primary analyses are complete.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Individualized Sleep Intervention |
The intervention involves a structured intervention education session soon after enrollment, where participants receive tailored and personalized instructions for sleep health and quality, then complete daily adherence surveys, and receive follow-up support to address any barriers. The approach builds on prior work to address cognitive and emotional challenges commonly experienced by adolescents with concussion. |
|
|
No Intervention Standard-of-Care |
Participants in the standard-of-care group will receive verbal and written sleep hygiene instructions at Visit 1, following established concussion management guidelines. These materials emphasize maintaining a consistent bedtime and reducing screen time before bed to support recovery. The approach reflects best practices informed by clinical recommendations for post-concussion care. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver
Detailed Description
Concussion is defined as a mild traumatic brain injury induced by biomechanical forces accompanied by an alteration in neurological status. Concussion recovery is complex, and many factors influence short- and long-term recovery outcomes. Among the deleterious effects observed after concussion, sleep-related problems are commonly reported and associated with increased risk of developing persisting post-concussion symptoms. Insufficient sleep is also commonly reported among uninjured adolescents, independent of concussion. In combination, adolescents with concussion are uniquely vulnerable to immediate and persisting sleep deficits. Currently prescribed sleep health recommendations for adolescents with a recent concussion remain vague, with limited evidence supporting intervention guidance. Given the documented relationship between post-concussion sleep problems and poor recovery outcomes, a multidimensional and prescriptive sleep health intervention initiated within the first month of a concussion may lead to improved patient outcomes. Using both patient-reported and objective (actigraphy) methods, our measurement approach will allow us to determine the efficacy of an innovative intervention to improve overall sleep health, concussion recovery, mental health, and academic engagement. The multidimensional sleep health intervention provides targeted and prescriptive recommendations for the patient and is developed from our existing pilot work. Specifically, the intervention addresses five areas with evidence to support post-concussion sleep deficits, including: 1) reduced time asleep, 2) inconsistent sleep/wake time, 3) more bed use for non-night-sleep purposes (e.g., napping), 4) excessive screen time before bed, and 5) night-time anxiety. Participants will be randomized to a multidimensional, prescriptive sleep health intervention or standard-of-care at Visit 1 (pre-intervention), undergo actigraphy monitoring and complete daily surveys for two weeks, return for re-assessment two weeks after Visit 1 (Visit 2, post-intervention), and 8 weeks after Visit 1 (Visit 3, persisting effects evaluation). Therefore, our objective is to discover if a multidimensional sleep health intervention among adolescents with a concussion (1) leads to faster symptom resolution time and better sleep quality and/or duration; and (2) affects persistent sleep habits, mental health, and academic engagement. We will use a two-group randomized clinical trial design (intervention, standard-of-care) with 3 assessments over an 8-week monitoring period. Our multidisciplinary investigative team, with expertise in concussion management, randomized clinical trials among adolescents with concussion, clinical trial design, and adolescent sleep behavior and psychology provides necessary experience to successfully complete this study. By challenging current sleep recommendations provided for adolescent patients with concussion, our project seeks to advance rehabilitation strategies for improved concussion management and overall improved health.
