Brain ConcussionNCT03781076
Sleep After Adolescent Concussion
A study testing Sleep Intervention in people with Brain Concussion, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Brain Concussion
- 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial
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.
Read the 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 adolescents (e.g., poor concentration, headache, emotional lability, slow thinking) seriously disrupt all aspects of a patient's functioning and impair quality of life. Although many youth recover quickly from mTBI, 30-60% remain symptomatic a month later. A biopsychosocial model was developed to account for protracted recoveries. In this model, acute symptoms result from a rapid cascade of injury-related neurometabolic and micro-structural aberrations. Since the vast majority of these abate within 1-3 weeks post-injury, persistent symptoms become increasingly difficult to explain physiologically, and psychosocial circumstances and patient behaviors become increasingly prominent contributors to impairment. There is reason to believe that, after mTBI, sleep is an underappreciated, modifiable behavior that drives impairment for youth with protracted recoveries. Care recommendations often mention sleep, but the field lacks empirically-supported guidelines and interventions for sleep after pediatric mTBI. Studies of mTBI in youth have used crude, unvalidated sleep measures. Also, there is no systematic research on non-injury contributors to poor sleep after mTBI, nor the nature and sources of advice that families receive. Lacking such data, one cannot develop empirically-based sleep recommendations. Finally, while there is reason to believe that a brief sleep intervention can alleviate mTBI symptoms in many youth who are recovering slowly, this needs to be tested in a well-powered clinical trial. The investigators are positioning to undertake such a trial, but must first document feasibility and acceptability of a sleep intervention after mTBI. To address these research gaps, the investigators are conducting a novel observational study and pilot clinical trial with these Aims:
Aim 1: Establish more detailed and definitive links between protracted mTBI recovery and sleep in 12-18-year-olds. The investigators are undertaking a prospective, observational study, objectively tracking sleep and assessing recovery 3-4 weeks post-mTBI. The study team will also explore potential contributors to inadequate sleep, including sleep-related behaviors and detail the nature and sources of information on sleep post mTBI.
Aim 2: Pilot-test a brief sleep intervention in the subset of youth who are slow to recover from mTBI and show short sleep. The study team will document feasibility and acceptability, and test its success in extending sleep duration.
- Conditions
- Brain Concussion
- Being tested
- Sleep Intervention
- Keywords
- Adolescence, Sleep
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep InterventionBehavioural
The study therapist will outline the biopsychosocial model of mTBI recovery, highlighting the shift from biological injury to behavior (especially sleep behavior) as key driver of symptoms. The intervention will then apply well-established strategies from the pediatric psychology and insomnia literatures, encouraging conjoint problem-solving by parent and youth with the shared goal of maximizing nocturnal sleep. These include: pre-planning, problem-solving, development of a positive routine, commitment to sleep-promoting behaviors, self-monitoring, and positive reinforcement. The therapist will also teach a brief, self-guided pre-sleep relaxation exercise that has been used in insomnia treatment to maximize the benefit of additional sleep opportunity.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention | Experimental | 1-hour brief behavioral intervention to improve sleep consolidation and nocturnal sleep duration. Receives: Behavioral: Sleep Intervention |
| Control | No intervention | In this "care as usual" arm, no specific behavioral sleep intervention is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Nocturnal sleep duration, quality, and regularity, as measured by wrist-mounted accelerometry (actigraphy). Although in theory there are upper limits on healthy sleep, in practice during adolescence better health is associated with longer nocturnal sleep, better sleep quality, and greater night-to-night consistency in sleep patterns.
Measured: 1-2 weeks
Concussion Symptoms
A primary outcome for the observational phase of the study, and a secondary outcome for the intervention phase, will be the Post-Concussion Symptom Scale (PCSS). On the PCSS, 21 common symptoms after concussion are rated on a 0-6 scale; for this study the focus will be on the summed total across items. Higher scores indicate greater symptom severity.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start7 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Note that the intervention portion of the study involves only a subset of participants. The larger bulk (planned n=108) will undergo only initial observation of sleep and concussion symptoms. The investigators plan to have 24 (those still symptomatic at 4 weeks post-concussion who do not get recommended sleep) undergo a pilot trial of a sleep intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Cincinnati Children's Research Foundation
- Responsible party
- Sponsor
- Investigators
- Dean W Beebe, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781076
- Sponsor's protocol ID
- IRB number 2018-5952
- Status last verified
- Jul 2020
- First submitted
- 18 Dec 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A deidentified data set may be available to qualified researchers who share specific research idea with the central contact person (Dr. Beebe, PI).
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03781076
- Acronym / sponsor ID
- IRB number 2018-5952
- Conditions
- Brain Concussion
- Keywords
- Adolescence, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Cincinnati Children's Research Foundation
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Dec 2018 (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.
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 adolescents (e.g., poor concentration, headache, emotional lability, slow thinking) seriously disrupt all aspects of a patient's functioning and impair quality of life. Although many youth recover quickly from mTBI, 30-60% remain symptomatic a month later. A biopsychosocial model was developed to account for protracted recoveries. In this model, acute symptoms result from a rapid cascade of injury-related neurometabolic and micro-structural aberrations. Since the vast majority of these abate within 1-3 weeks post-injury, persistent symptoms become increasingly difficult to explain physiologically, and psychosocial circumstances and patient behaviors become increasingly prominent contributors to impairment. There is reason to believe that, after mTBI, sleep is an underappreciated, modifiable behavior that drives impairment for youth with protracted recoveries. Care recommendations often mention sleep, but the field lacks empirically-supported guidelines and interventions for sleep after pediatric mTBI. Studies of mTBI in youth have used crude, unvalidated sleep measures. Also, there is no systematic research on non-injury contributors to poor sleep after mTBI, nor the nature and sources of advice that families receive. Lacking such data, one cannot develop empirically-based sleep recommendations. Finally, while there is reason to believe that a brief sleep intervention can alleviate mTBI symptoms in many youth who are recovering slowly, this needs to be tested in a well-powered clinical trial. The investigators are positioning to undertake such a trial, but must first document feasibility and acceptability of a sleep intervention after mTBI. To address these research gaps, the investigators are conducting a novel observational study and pilot clinical trial with these Aims:
Aim 1: Establish more detailed and definitive links between protracted mTBI recovery and sleep in 12-18-year-olds. The investigators are undertaking a prospective, observational study, objectively tracking sleep and assessing recovery 3-4 weeks post-mTBI. The study team will also explore potential contributors to inadequate sleep, including sleep-related behaviors and detail the nature and sources of information on sleep post mTBI.
Aim 2: Pilot-test a brief sleep intervention in the subset of youth who are slow to recover from mTBI and show short sleep. The study team will document feasibility and acceptability, and test its success in extending sleep duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Note that the intervention portion of the study involves only a subset of participants. The larger bulk (planned n=108) will undergo only initial observation of sleep and concussion symptoms. The investigators plan to have 24 (those still symptomatic at 4 weeks post-concussion who do not get recommended sleep) undergo a pilot trial of a sleep intervention.
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention | Experimental | Behavioral: Sleep Intervention1-hour brief behavioral intervention to improve sleep consolidation and nocturnal sleep duration. |
| Control | No intervention | –In this "care as usual" arm, no specific behavioral sleep intervention is provided. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
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 study therapist will outline the biopsychosocial model of mTBI recovery, highlighting the shift from biological injury to behavior (especially sleep behavior) as key driver of symptoms. The intervention will then apply well-established strategies from the pediatric psychology and insomnia literatures, encouraging conjoint problem-solving by parent and youth with the shared goal of maximizing nocturnal sleep. These include: pre-planning, problem-solving, development of a positive routine, commitment to sleep-promoting behaviors, self-monitoring, and positive reinforcement. The therapist will also teach a brief, self-guided pre-sleep relaxation exercise that has been used in insomnia treatment to maximize the benefit of additional sleep opportunity. | Behavioural | Sleep Intervention |
Primary outcome
Sleep
Time frame: 1-2 weeks
Nocturnal sleep duration, quality, and regularity, as measured by wrist-mounted accelerometry (actigraphy). Although in theory there are upper limits on healthy sleep, in practice during adolescence better health is associated with longer nocturnal sleep, better sleep quality, and greater night-to-night consistency in sleep patterns.
Concussion Symptoms
Time frame: 1-2 weeks
A primary outcome for the observational phase of the study, and a secondary outcome for the intervention phase, will be the Post-Concussion Symptom Scale (PCSS). On the PCSS, 21 common symptoms after concussion are rated on a 0-6 scale; for this study the focus will be on the summed total across items. Higher scores indicate greater symptom severity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Undecided. A deidentified data set may be available to qualified researchers who share specific research idea with the central contact person (Dr. Beebe, PI).
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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. This study is not recruiting at the moment.
Dean W Beebe, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
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 Brain Concussion, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: 1-2 weeks). The study lists 2 primary outcomes in all. 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 28 Jul 2020.