Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
NCT07082218 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-05-06
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.
Conditions
- Concussion (Diagnosis)
- Concussion, Mild Traumatic Brain Injury
- Treatment
- Sleep Health
- Depression, Anxiety
Interventions
- BEHAVIORAL
-
Sleep 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.
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
David R Howell, PhD · University of Colorado Denver | Anschutz
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2027-05-01
- Completion
- 2027-06-15
Countries
- United States
Study Locations
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