No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
10 – 19
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
54 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for adolescents aged 10 to 19 who have recently had a concussion and are experiencing symptoms. Participants will join a program aimed at improving sleep and overall recovery compared to standard care.
Are You a Good Fit for This Trial?
You may be able to join if
I am symptomatic at the time of enrollment.
I have been diagnosed with a concussion by a healthcare provider.
I am between 10 and 19 years old.
You may not be able to join if
I have a history of treatment for sleep-related disorders before my concussion.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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…
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
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