Recruiting soon

SCOREMultidimensional Sleep Health for Adolescent Concussion Recovery

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What is being tested

Sleep Intervention

Behavioral
Who is being recruted

Brain Injuries, Traumatic+8

+ Brain Concussion

+ Brain Diseases

From 10 to 19 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactDavid R Howell, PhDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on improving recovery from concussion in adolescents by addressing sleep-related issues. Concussion is a type of mild brain injury that affects neurological function, and recovery can be complicated by sleep problems. Adolescents, whether they have a concussion or not, often experience insufficient sleep, making those with a concussion particularly vulnerable. The study aims to test a new sleep health intervention that is more detailed and specific than current general guidelines. By improving sleep patterns and quality in the first month after a concussion, this intervention could enhance recovery, mental health, and academic performance. Participants in the study are adolescents with a recent concussion. They will be randomly assigned to either the new sleep health intervention or the standard care. The intervention includes specific recommendations to improve sleep, such as reducing screen time before bed and establishing consistent sleep schedules. Participants will wear a device called an actigraph to monitor their sleep and will fill out daily surveys. The study will assess their progress at two weeks and again at eight weeks after starting the intervention. The goal is to see if the intervention improves sleep quality and recovery speed, as well as long-term sleep habits and overall well-being.

Official TitleMultidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial 
Principal SponsorUniversity of Colorado, Denver
Study ContactDavid R Howell, PhDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain Injuries, TraumaticBrain ConcussionBrain DiseasesBrain InjuriesCentral Nervous System DiseasesCraniocerebral TraumaNervous System DiseasesWounds and InjuriesWounds, NonpenetratingHead Injuries, ClosedTrauma, Nervous System

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Colorado Denver

Aurora, United StatesSee the location
Recruiting soonOne Study Center