RecruitingNot ApplicableNCT07082218

Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

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


Sponsor

University of Colorado, Denver

Enrollment

54 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 19 Years

Inclusion Criteria3

  • 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
  • -19 years of age (aligned with World Health Organization definition of 'adolescent')

Exclusion Criteria1

  • History of treatment for pre-concussion sleep-related disorders

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Interventions

BEHAVIORALSleep Intervention

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.


Locations(1)

University of Colorado Denver

Aurora, Colorado, United States

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NCT07082218


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