RecruitingRecruiting
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
NCT07082218 · University of Colorado, Denver
In plain English
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Official title
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial
About this study
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.
Eligibility criteria
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
Enrollment target: 54 participants
Allocation: randomized
Masking: double
Age groups: child, adult
Timeline
Starts: 2025-09-01
Estimated completion: 2027-06-15
Last updated: 2026-05-06
Interventions
Behavioral: Sleep Intervention
Primary outcomes
- • Concussion symptom resolution time (Through study completion, an average of 8 weeks)
Sponsor
University of Colorado, Denver · other
Contacts & investigators
ContactDavid R Howell, PhD · contact · David.Howell@CUAnschutz.edu · 7207771502
ContactKatelyn Hurlburt, BS · contact · Katelyn.Hurlburt@CUAnschutz.edu · 7207771502
InvestigatorDavid R Howell, PhD · principal_investigator, University of Colorado Denver | Anschutz
All locations (1)
University of Colorado DenverRecruiting
Aurora, Colorado, United States