Sleep Intervention for Concussion

(SCORE Trial)

Overseen By Katelyn Hurlburt, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pre-concussion sleep disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria

I am experiencing symptoms with a PCSI score of 9 or higher.

I am between 10 and 19 years old.

Exclusion Criteria

I have been treated for sleep disorders before a concussion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants are randomized to either the individualized sleep intervention or standard-of-care group and receive initial instructions

1 day

1 visit (in-person)

Intervention

Participants undergo actigraphy monitoring and complete daily surveys for two weeks

2 weeks

Daily monitoring (remote)

Post-intervention assessment

Participants return for re-assessment to evaluate the effects of the intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for persisting effects of the intervention on sleep health, mental health, and academic engagement

8 weeks

1 visit (in-person)

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?

Group I: Individualized Sleep Intervention Experimental Treatment 1 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.

Group II: Standard-of-Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. patlynk.com patlynk.com/trial/NCT07082218

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6306025/

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/download

Minerva 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:.

4. withpower.com withpower.com/trial/phase-brain-concussion-8-2025-c0ad8

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_athletes

The 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 ...

6. researchstudies.cuanschutz.edu researchstudies.cuanschutz.edu/Study/24-2571

Find a Research Study To discover the efficacy of a multidimensional sleep health intervention on concussion symptom resolution time and sleep health assessments following ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03781076

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 ...

8. reporter.nih.gov reporter.nih.gov/project-details/11220840

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 ...