Sleep After Adolescent Concussion



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:12 - 18
Updated:1/2/2019
Start Date:December 7, 2018
End Date:October 31, 2019
Contact:Catharine Whitacre
Email:Catharine.Whitacre@cchmc.org
Phone:513-636-5360

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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.

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.

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).
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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