Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

NCT07082218 | Recruiting DMC

• 1 other identifier: 24-2571
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intervention; mild traumatic brain injury; sleep quality

Outcome Measures

Primary Outcomes (1)

• Concussion symptom resolution time

  The day when symptoms are no longer experienced. As some may endorse symptoms independent of a concussion.

  Through study completion, an average of 8 weeks

Secondary Outcomes (8)

• Sleep duration

  Through intervention completion, an average of two weeks

• Sleep quality

  Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)

• Sleep disorders symptoms

  Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)

• Sleep behaviors

  Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)

• Sleep onset and continuity

  Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)

Study Arms (2)

Individualized Sleep Intervention

EXPERIMENTAL

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.

Behavioral: Sleep Intervention

Standard-of-Care

NO INTERVENTION

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.

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.

Individualized Sleep Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Disease; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• David R Howell, PhD

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David R Howell, PhD

CONTACT

7207771502; David.Howell@CUAnschutz.edu

Katelyn Hurlburt, BS

CONTACT

7207771502; Katelyn.Hurlburt@CUAnschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study principal investigator (PI) and the biostatistician will not know group assignments until after the primary analyses are complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will use a block stratified randomized clinical trial design. Our strata factor are the biological variable of sex and form of assessment (remote vs. in-person)

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The IPD and information will be available 6 months after the end of the trial (start date), for three years (end date)
• Access Criteria: Researchers with adequate justification for reasonable as a part of other (e.g., meta-analytic) studies. Access to data will be granted via email communication.

Locations

US (1)