Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorUniversity of Colorado, Denver

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sleep Intervention

    Behavioral

    The 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

54 Participants
are divided into 2 treatment groups
Group A: Individualized Sleep InterventionExperimental treatment 1 intervention
Group B: Standard-of-CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Concussion symptom resolution time

The day when symptoms are no longer experienced. As some may endorse symptoms independent of a concussion.

Time frame
Through study completion, an average of 8 weeks

Secondary outcomes

1

Sleep duration

Participants will wear a commercially available actigraphy device to quantify nightly sleep duration.

Time frame
Through intervention completion, an average of two weeks
2

Sleep quality

Self-reported measure of sleep quality perception completed via the Pittsburgh Sleep Quality Index. Scale=0-21, higher = worse sleep quality

Time frame
Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
3

Sleep disorders symptoms

Sleep Disorders Inventory for Students; SDIS. T scores range from 0-90, and higher scores indicate more severe sleep disorder

Time frame
Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
4

Sleep behaviors

Adolescent Sleep-Wake Scale; ASWS. Scores range from 28-168, with higher scores indicating better sleep quality.

Time frame
Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)

Other outcomes

Sponsors and contacts

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