Multidimensional Sleep Health Intervention to Optimize Concussion Recovery (NCT07082218) | Clinical Trial Compass
RecruitingNot Applicable
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
United States54 participantsStarted 2025-09-10
Plain-language 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.
Who can participate
Age range
10 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on sleep health as a way to help concussion recovery — could you explain what 'multidimensional sleep health' means in practice, and why improving sleep might speed up my symptom resolution?
2The trial is listed as Phase NA, which often means it's testing a behavioral or non-drug intervention — does that change the risk profile compared to a medication trial, and what are the potential downsides of participating?
3Since the study is also tracking depression and anxiety alongside concussion symptoms, does that mean I'd be getting some mental health support as part of the intervention, and is that something I currently need?
4The primary outcome they're measuring is how quickly concussion symptoms resolve — based on my current symptoms and how long I've already been recovering, does my doctor think I'm a good fit to discuss this trial further?
5Are there standard concussion treatments or sleep interventions already proven to work that I should try first before considering enrolling in a research study like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concussion symptom resolution time
Timeframe: Through study completion, an average of 8 weeks