About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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')
Disqualifiers
History of treatment for pre-concussion sleep-related disorders
Trial design
Parallel
Treatments tested in this trial
Sleep Intervention
BehavioralThe investigators will randomly assign participants (adolescents with concussion) to a personalized sleep schedule and sleep health recommendation, based on a meeting with an administrator after enrollment and randomization. They will undergo testing prior to the intervention, after the intervention (2 weeks after the initial visit, intervention length=2 weeks), and 6 weeks after intervention completion.
Treatment groups
Trial outcomes
Primary outcomes
Concussion symptom resolution time
The day when symptoms are no longer experienced. As some may endorse symptoms independent of a concussion.
Secondary outcomes
Sleep duration
Participants will wear a commercially available actigraphy device to quantify nightly sleep duration.
Sleep quality
Self-reported measure of sleep quality perception completed via the Pittsburgh Sleep Quality Index. Scale=0-21, higher = worse sleep quality
Sleep disorders symptoms
Sleep Disorders Inventory for Students; SDIS. T scores range from 0-90, and higher scores indicate more severe sleep disorder
Sleep behaviors
Adolescent Sleep-Wake Scale; ASWS. Scores range from 28-168, with higher scores indicating better sleep quality.
Sponsors and contacts
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