Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 10 Years to 19 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 2 visits, 8 visits
- Time periods mentioned: 2 weeks
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomized to a multidimensional, prescriptive sleep health intervention or standard-of-care at Visit 1 (pre-intervention), undergo actigraphy monitoring and complete daily surveys for two weeks, return for re-assessment two weeks after Visit 1 (Visit 2, post-intervention), and 8 weeks after Visit 1 (Visit 3, persisting effects evaluation)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a sleep plan helps young people ages 10–19 recover faster from a recent concussion, a type of brain injury. It compares the plan with usual sleep advice to see if it improves symptoms, sleep, mental health, and how involved they are in school.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Are 10–19 years old.
- Still have symptoms when joining, with a score of 9 or higher on the Post-Concussion Symptom Inventory, a symptom checklist.
- Have a concussion diagnosed by a healthcare provider using American Congress of Rehabilitation Medicine guidelines.
Who can't join
- Have been treated for a sleep disorder that started before the concussion.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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 sites (1)
CO
- University of Colorado Denver · Aurora, CO 80045David R Howell, PhD · Principal investigatorMore trials in Aurora