Clinical trial NCT03781076: Sleep After Adolescent Concussion
Official title: Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Adolescence, Sleep
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Cincinnati Children's Research Foundation
First posted: 2018-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Sleep
timeFrame: 1-2 weeks
measure: Concussion Symptoms
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Dean W Beebe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: