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Sleep After Adolescent Concussion

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ClinicalTrials.gov Identifier: NCT03781076
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborator:
Cincinnati Children's Research Foundation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Concussion Behavioral: Sleep Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The intervention explicitly involves behavior change, so the participant cannot be blinded. The outcomes assessment involves objective monitors, and therefore can be considered blind.
Primary Purpose: Treatment
Official Title: Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Concussion

Arm Intervention/treatment
Experimental: Sleep Intervention
1-hour brief behavioral intervention to improve sleep consolidation and nocturnal sleep duration.
Behavioral: Sleep Intervention
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.

No Intervention: Control
In this "care as usual" arm, no specific behavioral sleep intervention is provided.



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781076


Contacts
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Contact: Catharine Whitacre 513-636-5360 Catharine.Whitacre@cchmc.org
Contact: Dean W Beebe, Ph.D. 513-636-3489 dean.beebe@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Cincinnati Children's Research Foundation
Investigators
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Principal Investigator: Dean W Beebe, Ph.D. Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03781076     History of Changes
Other Study ID Numbers: IRB number 2018-5952
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Adolescence, Sleep
Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating