Sleep After Adolescent Concussion

NCT03781076 | Completed

• 1 other identifier: IRB number 2018-5952
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion

Keywords

Adolescence, Sleep

Outcome Measures

Primary Outcomes (2)

• Sleep

  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.

  1-2 weeks

• Concussion Symptoms

  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.

  1-2 weeks

Study Arms (2)

Sleep Intervention

EXPERIMENTAL

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

Behavioral: Sleep Intervention

Control

NO INTERVENTION

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

Interventions

Sleep Intervention 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.

Sleep Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Cincinnati Children's Research Foundation: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Dean W Beebe, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The intervention explicitly involves behavior change, so the participant cannot be blinded. The outcomes assessment involves objective monitors, and therefore can be considered blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: December 7, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

US (1)