Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07082218
Status
Recruiting
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Conditions

  • Concussion (Diagnosis)
  • Concussion, Mild Traumatic Brain Injury
  • Depression, Anxiety
  • Sleep Health
  • Treatment

Eligibility Criteria

Sex
ALL
Age
10 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Intervention — BEHAVIORAL
    The investigators will randomly assign participants (adolescents with concussion) to a personalized sleep schedule and sleep health recommendation, based on a meeting with an administrator after enrollment and randomization. They will undergo testing prior to the intervention, after the intervention (2 weeks after the initial visit, intervention length=2 weeks), and 6 weeks after intervention completion.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
May 2026
Primary completion
May 1, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Concussion symptom resolution time [ Time Frame: Through study completion, an average of 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045
David R Howell, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Denver· Aurora, CO

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