An interventional study of Sleep Intervention in Concussion (Diagnosis), Concussion, Mild Traumatic Brain Injury and Treatment, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
Concussion is defined as a mild traumatic brain injury induced by biomechanical forces accompanied by an alteration in neurological status. Concussion recovery is complex, and many factors influence short- and long-term recovery outcomes. Among the deleterious effects observed after concussion, sleep-related problems are commonly reported and associated with increased risk of developing persisting post-concussion symptoms. Insufficient sleep is also commonly reported among uninjured adolescents, independent of concussion. In combination, adolescents with concussion are uniquely vulnerable to immediate and persisting sleep deficits. Currently prescribed sleep health recommendations for adolescents with a recent concussion remain vague, with limited evidence supporting intervention guidance. Given the documented relationship between post-concussion sleep problems and poor recovery outcomes, a multidimensional and prescriptive sleep health intervention initiated within the first month of a concussion may lead to improved patient outcomes. Using both patient-reported and objective (actigraphy) methods, our measurement approach will allow us to determine the efficacy of an innovative intervention to improve overall sleep health, concussion recovery, mental health, and academic engagement. The multidimensional sleep health intervention provides targeted and prescriptive recommendations for the patient and is developed from our existing pilot work. Specifically, the intervention addresses five areas with evidence to support post-concussion sleep deficits, including: 1) reduced time asleep, 2) inconsistent sleep/wake time, 3) more bed use for non-night-sleep purposes (e.g., napping), 4) excessive screen time before bed, and 5) night-time anxiety. 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). Therefore, our objective is to discover if a multidimensional sleep health intervention among adolescents with a concussion (1) leads to faster symptom resolution time and better sleep quality and/or duration; and (2) affects persistent sleep habits, mental health, and academic engagement. We will use a two-group randomized clinical trial design (intervention, standard-of-care) with 3 assessments over an 8-week monitoring period. Our multidisciplinary investigative team, with expertise in concussion management, randomized clinical trials among adolescents with concussion, clinical trial design, and adolescent sleep behavior and psychology provides necessary experience to successfully complete this study. By challenging current sleep recommendations provided for adolescent patients with concussion, our project seeks to advance rehabilitation strategies for improved concussion management and overall improved health.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 54 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
The intervention involves a structured intervention education session soon after enrollment, where participants receive tailored and personalized instructions for sleep health and quality, then complete daily adherence surveys, and receive follow-up support to address any barriers. The approach builds on prior work to address cognitive and emotional challenges commonly experienced by adolescents with concussion.
Behavioral: Sleep Intervention
Participants in the standard-of-care group will receive verbal and written sleep hygiene instructions at Visit 1, following established concussion management guidelines. These materials emphasize maintaining a consistent bedtime and reducing screen time before bed to support recovery. The approach reflects best practices informed by clinical recommendations for post-concussion care.
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.
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
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
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)
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)
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)
Sleep onset and continuity
Patient-Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance and Sleep-Related Impairment short forms. Scores are converted to T-scores, ranging from 35-75 with higher scores indicating more severe sleep problems
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Sleep chronotype
Morningness/Eveningness Scale for Children; MESC. Scores range from 10-50, with higher scores indicating a stronger morning preference and lower scores indicating a stronger evening preference.
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Mental Health
PROMIS Global Pediatric Profiles 25, anxiety and depressive symptom domains. Scores are converted to T-scores with a range from 30-80, where higher scores indicate a more severe endorsement of anxiety and depressive symptoms.
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Academic engagement
Identification with School Questionnaire; ISQ. Scores range from 16 to 80, with higher scores indicating a very high identification with school.
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Plan to share: Yes — Primary deidentified outcome variables, demographics, and unblinded groups will be available based upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: The IPD and information will be available 6 months after the end of the trial (start date), for three years (end date)
Access criteria: Researchers with adequate justification for reasonable as a part of other (e.g., meta-analytic) studies. Access to data will be granted via email communication.
Data sharing details ↗ · medschool.cuanschutz.edu
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2027, 19 months after the start.
Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 19 months is below that.
Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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