Concussion (Diagnosis)SCORENCT07082218
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery
A study testing Sleep Intervention in people with Concussion (Diagnosis) and Concussion, Mild Traumatic Brain Injury, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Concussion (Diagnosis), Concussion, Mild Traumatic Brain Injury, Treatment
- What is being tested?
- Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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')
Who cannot join
- History of treatment for pre-concussion sleep-related disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
David R Howell, PhD
About this study
Official title: Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Concussion (Diagnosis), Concussion, Mild Traumatic Brain Injury, Treatment, Sleep Health, Depression, Anxiety
- Being tested
- Sleep Intervention
- Keywords
- intervention, mild traumatic brain injury, sleep quality
- Medical subject headings
- Brain Concussion, Disease, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Sleep Intervention | Experimental | 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. Receives: Behavioral: Sleep Intervention |
| Standard-of-Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concussion symptom resolution time
The day when symptoms are no longer experienced. As some may endorse symptoms independent of a concussion.
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (8)
Sleep duration
Participants will wear a commercially available actigraphy device to quantify nightly sleep duration.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start10 Sep 2025
- Primary completion1 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will use a block stratified randomized clinical trial design. Our strata factor are the biological variable of sex and form of assessment (remote vs. in-person)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Howell, PhD, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082218
- Sponsor's protocol ID
- 24-2571
- Acronym
- SCORE
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary deidentified outcome variables, demographics, and unblinded groups will be available based upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07082218
- Acronym / sponsor ID
- SCORE / 24-2571
- Conditions
- Concussion (Diagnosis), Concussion, Mild Traumatic Brain Injury, Treatment, Sleep Health, Depression, Anxiety
- Keywords
- intervention, mild traumatic brain injury, sleep quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use a block stratified randomized clinical trial design. Our strata factor are the biological variable of sex and form of assessment (remote vs. in-person)
| Arm | Type | Receives |
|---|---|---|
| Individualized Sleep Intervention | Experimental | Behavioral: Sleep InterventionThe 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. |
| Standard-of-Care | No 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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')
Key exclusion criteria (1 listed)
- History of treatment for pre-concussion sleep-related disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep InterventionThe 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. | Behavioural | Individualized Sleep Intervention |
Primary outcome
Concussion symptom resolution time
Time frame: Through study completion, an average of 8 weeks
The day when symptoms are no longer experienced. As some may endorse symptoms independent of a concussion.
8 secondary outcomes
Sleep duration
Time frame: Through intervention completion, an average of two weeks
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
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Sleep behaviors
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Sleep onset and continuity
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Sleep chronotype
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Mental Health
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Academic engagement
Time frame: Baseline (Visit 1), Visit 2 (2 weeks after Visit 1), and Visit 3 (8 weeks after Visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Primary deidentified outcome variables, demographics, and unblinded groups will be available based upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David R Howell, PhD principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention in people with Concussion (Diagnosis) and Concussion, Mild Traumatic Brain Injury, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David R Howell, PhD (7207771502, David.Howell@CUAnschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concussion symptom resolution time (time frame: Through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.