Recruiting

Sleep Health Intervention

Sponsor:

University of Colorado, Denver

Code:

NCT07082218

Conditions

Concussion (Diagnosis)

Concussion, Mild Traumatic Brain Injury

Treatment

Sleep Health

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Not accepted

Interventions

Sleep Intervention

Study Details

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

Study ID

NCT07082218

Start date

Sep 10, 2025

Status verified date

Jun, 2026

Completion date

Jun 15, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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')

Exclusion Criteria:

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David R Howell, PhD

7207771502David.Howell@CUAnschutz.edu

Katelyn Hurlburt, BS

7207771502Katelyn.Hurlburt@CUAnschutz.edu

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

David R Howell, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • intervention
  • mild traumatic brain injury
  • sleep quality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-18.