Sleep Intervention for Concussion
(SCORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new sleep program to help adolescents recover from concussions more quickly. The goal is to determine if personalized sleep advice improves sleep quality, mental health, and school performance more effectively than standard guidelines. Participants receive either a tailored sleep plan with follow-up support or standard sleep advice for concussion recovery. Teens diagnosed with a concussion and experiencing symptoms might be suitable for this study.
As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery strategies for future patients.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this sleep health intervention is safe for adolescents with a concussion?
Research shows that sleep health programs can be safe and helpful for teens recovering from a concussion. Past studies have used similar sleep programs without reports of serious side effects. These programs focus on improving sleep habits, such as setting a regular bedtime and reducing screen time before bed.
The Multidimensional Sleep Health Intervention aims to aid concussion recovery by enhancing sleep quality. This structured program offers personalized sleep tips and support, with the goal of helping teens recover faster through better sleep. So far, studies have not shown any harmful effects from these types of sleep programs.
While this trial seeks to provide more precise recommendations, past research indicates that the program has been well-tolerated. Participants follow a plan to improve sleep without any known risks, suggesting that the treatment is generally safe for teens with concussions.12345Why are researchers excited about this trial?
Researchers are excited about the Multidimensional Sleep Health Intervention for concussions because it offers a personalized approach to sleep management, which is not just about giving general advice. Unlike standard care, which typically involves generic sleep hygiene tips, this intervention tailors sleep guidance to each individual's needs, addressing specific cognitive and emotional challenges faced by adolescents with concussions. This personalized strategy, coupled with daily adherence surveys and follow-up support, aims to improve sleep quality more effectively, potentially leading to better overall recovery outcomes.
What evidence suggests that this sleep intervention is effective for concussion recovery?
This trial will compare an Individualized Sleep Intervention with Standard-of-Care for adolescents recovering from a concussion. Studies have shown that better sleep is important for concussion recovery. Focusing on good sleep habits has helped teenagers recover faster by improving sleep quality and duration. For example, some research found that addressing sleep problems can accelerate symptom resolution. By providing personalized sleep advice, the Individualized Sleep Intervention in this trial also aims to improve mental health and school performance. These findings suggest that focusing on sleep can significantly aid teens dealing with concussions.12678
Who Is on the Research Team?
David R Howell, PhD
Principal Investigator
University of Colorado Denver | Anschutz
Are You a Good Fit for This Trial?
This trial is for adolescents who recently had a concussion and are experiencing poor sleep, which may affect their recovery. They should not have liver disease or severe mental health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-intervention
Participants are randomized to either the individualized sleep intervention or standard-of-care group and receive initial instructions
Intervention
Participants undergo actigraphy monitoring and complete daily surveys for two weeks
Post-intervention assessment
Participants return for re-assessment to evaluate the effects of the intervention
Follow-up
Participants are monitored for persisting effects of the intervention on sleep health, mental health, and academic engagement
What Are the Treatments Tested in This Trial?
Interventions
- Multidimensional Sleep Health Intervention
Trial Overview
The study tests whether a detailed sleep intervention helps teens recover faster from concussions by improving symptom resolution time, sleep quality, duration, habits, mental health, and academic engagement compared to standard post-concussion advice.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Citations
Multidimensional Sleep Health for Adolescent Concussion ...
This study focuses on improving recovery from concussion in adolescents by addressing sleep-related issues. Concussion is a type of mild ...
A Multidimensional Approach to Post-concussion ...
We review current evidence and controversies concerning the use of the terms post-concussion symptoms vs. syndrome, its diagnosis, etiology, prevalence, ...
3.
minerva-access.unimelb.edu.au
minerva-access.unimelb.edu.au/bitstreams/30b0fef5-fb90-5d83-a5dc-6e72a8ed24d5/downloadMinerva Access is the Institutional Repository of The University of ...
Effectiveness of the CE intervention will be ... to- treat population where outcome data ... intervention on parent- reported postconcussion pediatric symptoms:.
Sleep Intervention for Concussion (SCORE Trial)
Trial Overview The study tests whether a detailed sleep intervention helps teens recover faster from concussions by improving symptom resolution time, sleep ...
5.
researchgate.net
researchgate.net/publication/366683836_The_association_between_sleep_and_physical_activity_with_persisting_post-concussion_symptoms_among_adolescent_athletesThe association between sleep and physical activity with ...
Results: Of the 49 participants, 47% (n=23, mean symptom resolution=57±23 days post-injury) developed PPCS and 53% (n=26, mean symptom ...
Find a Research Study
To discover the efficacy of a multidimensional sleep health intervention on concussion symptom resolution time and sleep health assessments following ...
NCT03781076 | Sleep After Adolescent Concussion
The investigators are undertaking a prospective, observational study, objectively tracking sleep and assessing recovery 3-4 weeks post-mTBI. The study team will ...
RePORT RePORTER - National Institutes of Health (NIH) |
Leveraging omics data to understand sleep health and its consequences ... Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized ...
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