Status:
COMPLETED
Sleep After Adolescent Concussion
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Cincinnati Children's Research Foundation
Conditions:
Brain Concussion
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
The purpose of this research study is to learn more about how sleep changes as teens recover from concussions. We also want to learn if we can improve sleep in teens who have concussions.
Detailed Description
Mild traumatic brain injuries (mTBI), also called concussions, affect millions of individuals and cost over $17 billion in the US annually. Despite the term "mild," mTBI symptoms in children and adole...
Eligibility Criteria
Inclusion
- 12-18 years old
- Had a mild TBI or concussion (blow to the head associated with loss of consciousness\<30 min, amnesia, or alteration in mental status) \<3 weeks prior to study participation.
Exclusion
- lowest Glasgow coma scale (GCS) \<13 or imaging evidence of intracranial abnormality (i.e., too severe)
- previous more severe TBI or mTBI within the prior 3 months (potential overlapping recoveries)
- extracranial injury with an Abbreviated Injury Severity Scale \>4 for that region (non-mTBI injuries)
- non-fluent in English
- previously-diagnosed intellectual disability, autism, bipolar disorder, or psychosis (could impact measure validity)
- use of medication known to substantially affect sleep (e.g., stimulant).
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03781076
Start Date
December 7 2018
End Date
December 31 2019
Last Update
July 28 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229