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Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 19
Healthy Volunteers: f
View:

• 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')

Locations
United States
Colorado
University of Colorado Denver
RECRUITING
Aurora
Contact Information
Primary
David R Howell, PhD
David.Howell@CUAnschutz.edu
7207771502
Backup
Katelyn Hurlburt, BS
Katelyn.Hurlburt@CUAnschutz.edu
7207771502
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2027-06-15
Participants
Target number of participants: 54
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov