Sleep After Adolescent Concussion

Brain Concussion Clinical Trial

Official title: Sleep After Adolescent Mild Traumatic Brain Injury (mTBI, Aka Concussion): Nature, Contributors, and a Pilot Clinical Trial

Status Completed

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Concussion

• NCT number: NCT03781076
• Study type: Interventional
• Source: Children's Hospital Medical Center, Cincinnati
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Completion date: December 31, 2019