Sleep After Adolescent Concussion

NCT ID: NCT03781076

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2019-12-31

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.

Conditions

Brain Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sleep Intervention

1-hour brief behavioral intervention to improve sleep consolidation and nocturnal sleep duration.

Group Type: EXPERIMENTAL

Sleep Intervention

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cincinnati Children's Research Foundation

UNKNOWN

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean W Beebe, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

IRB number 2018-5952

Identifier Type: -

Identifier Source: org_study_id