Multidimensional sleep health intervention to optimize concussion recovery: a randomized clinical trial

The National Institute of Child Health and Human Development (NICHD) awarded $346,500 in Project Grant funding to the University of Colorado-Denver under the Child Health and Human Development Extramural Research program (CFDA 93.865) for a two-year randomized clinical trial examining a multidimensional sleep health intervention to optimize concussion recovery in adolescents. The award, effective July 1, 2025 through June 30, 2027, supports research investigating the relationship between sleep deficits and post-concussion outcomes, utilizing both patient-reported and objective actigraphy measurement methods to evaluate intervention efficacy.

The research deliverables include development and testing of a prescriptive, multidimensional sleep health intervention addressing five evidence-based areas contributing to post-concussion sleep deficits: reduced time asleep, inconsistent sleep/wake schedules, excessive daytime bed use, screen time before bed, and nighttime anxiety. The intervention will be compared against standard care in a randomized trial design, with the goal of generating data demonstrating improved overall sleep health, concussion recovery outcomes, mental health status, and academic engagement in the adolescent population. Performance of the research activities is based in Colorado.

Abstract

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, rcts 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.