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Multidimensional Sleep Health for Adolescent Concussion Recovery

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What is being tested

Sleep Intervention

Behavioral
Who is being recruted

Concussion (Diagnosis)
+2

+ Concussion, Mild Traumatic Brain Injury
+ Treatment
From 10 to 19 Years
+4 Eligibility Criteria

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, PhD
Last updated: July 24, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual 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, PhD
Last updated: July 24, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 10 to 19 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Concussion (Diagnosis)
Concussion, Mild Traumatic Brain Injury
Treatment
Sleep Health
Depression, Anxiety
Criteria
3 inclusion criteria required to participate
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')
1 exclusion criteria prevent from participating
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
2 intervention groups 

are 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.
Group II
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.
Study Objectives
Primary Objectives

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

Identification with School Questionnaire; ISQ. Scores range from 16 to 80, with higher scores indicating a very high identification with school.

Participants will wear a commercially available actigraphy device to quantify nightly sleep duration.

Self-reported measure of sleep quality perception completed via the Pittsburgh Sleep Quality Index. Scale=0-21, higher = worse sleep quality

Sleep Disorders Inventory for Students; SDIS. T scores range from 0-90, and higher scores indicate more severe sleep disorder

Adolescent Sleep-Wake Scale; ASWS. Scores range from 28-168, with higher scores indicating better sleep quality.

Patient-Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance and Sleep-Related Impairment short forms. Scores are converted to T-scores, ranging from 35-75 with higher scores indicating more severe sleep problems

Morningness/Eveningness Scale for Children; MESC. Scores range from 10-50, with higher scores indicating a stronger morning preference and lower scores indicating a stronger evening preference.

PROMIS Global Pediatric Profiles 25, anxiety and depressive symptom domains. Scores are converted to T-scores with a range from 30-80, where higher scores indicate a more severe endorsement of anxiety and depressive symptoms.

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 DenverAurora, United StatesSee the location
Recruiting soonOne Study Center