Addressing Sleep in Adolescents Post-Concussion ("ASAP Study")

NCT05736692 | Withdrawn

• 1 other identifier: 2022-0608
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hundreds of thousands of adolescents experience protracted recoveries from concussion, which can affect all aspects of their lives and create family and societal burden. Research suggests that interventions to improve their sleep quantity and/or quality could improve recovery from concussion, but current treatment models are costly and onerous for families, fit poorly with integrated care models, and leave youth and their families to suffer months of protracted burden. This study will evaluate the efficacy of a promising brief behavioral sleep intervention, which could prove to be a powerful new tool to head off protracted symptom burden.

Conditions

Concussion, Brain; Sleep Disorder

Outcome Measures

Primary Outcomes (3)

• Objective Sleep Assessment

  Youth will wear a wrist-based actigraph/accelerometer and report sleep-wake patterns on a nightly sleep diary. This low-burden approach tracks sleep in the natural setting and yields objective estimates that have \>90% agreement with EEG-defined sleep in adolescents. Following the PI's established protocols, during the assessment portion of each visit, study staff will review the uploaded data and sleep diary conjointly with the parent and youth to identify and exclude artifacts (e.g., unit removal). The primary sleep endpoints (Aims 1-3) will be sleep period on weeknights (onset to offset) and percent of that period actually spent asleep.

  Measured during the week leading up to each of the three study visits

• Persistent Post-Concussive Symptom Severity

  The Post-Concussion Symptom Scale (PCSS) is a well-validated self-report form that asks about the presence/severity of 22 symptoms. Consistent with prior recovery studies, youth will be asked to endorse only those items that started at the time of injury and persist. The primary PCSS severity endpoint (Aims 1-3) will be total score, excluding items asking about sleep.

  Measured at all three study visits

• Overall Daily Functioning

  Parent- and self-report on the 23-item Pediatric Quality of Life (PedsQL generic) questionnaires. The PedsQL has extensive psychometric support in children and adolescents with a variety of conditions, is a suggested common data element in TBI research, and is sensitive to adolescent PPCS. The primary daily functioning endpoints (Aims 2 \& 3) will be parent- and self-report PedsQL total scores.

  Measured at all three study visits

Study Arms (2)

Brief Sleep Intervention

EXPERIMENTAL

1-session intervention designed to improve adolescent sleep quality and/or quantity.

Behavioral: Brief Sleep Intervention

Control

NO INTERVENTION

Care as Usual. Those in this condition will be asked to continue their scheduled/prescribed care until the next study assessment. Note that, to ensure that all participants (control and sleep intervention) are offered the current standard of care, all will get a simple handout on sleep hygiene and any who is not receiving follow-up care will be referred to the Brain Health and Wellness Center (the multidisciplinary program to which all PCSS care at Cincinnati Children's is routed).

Interventions

Brief Sleep Intervention BEHAVIORAL

A \~50-minute semi-structured intervention based on the behavioral sleep medicine literature, particularly for adolescent insomnia, focused on key elements that can be addressed in one session. Treatment elements include engaging motivation, goal setting, barrier identification, problem-solving, pre-planning, self-monitoring, and setting rewards. The interventionist will be sensitized to barriers to sleep quality and quantity particularly relevant during adolescence, including job/work, homework, and social obligations, use of nicotine and caffeine, and social media and electronic devices. The interventionist will converse primarily with the adolescent, but parents will remain in the room as a support in problem-solving and executing therapeutic plans.

Brief Sleep Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Had a concussion resulting in at least one persisting symptom at study entry 3-6 weeks later (initial visit 4-7 weeks post-injury). Those with Persistent Post-Concussive Symptoms (PPCS) and poor sleep at the initial visit will be eligible for randomization. PPCS will be defined as: concussion (blow to the head with loss of consciousness \<30 min, amnesia, or alteration in mental status) resulting in \>1 new symptom on the Post-Concussion Symptom Scale that persists at at least 4 weeks post-injury. Poor sleep quantity or quality will be defined as: (a) objective actigraphy showing less than recommended sleep (\<8 hours) on school nights or spending \<85% of the sleep period actually asleep, or (b) self-report of poor sleep quality (score \>5 on the Pittsburgh Sleep Quality Index).

You may not qualify if:

• (a) lowest injury-related Glasgow coma scale (GCS) \<13 or imaging evidence of intracranial abnormality, (b) previous more severe TBI or previous mTBI from which recovery was incomplete, (c) associated extracranial injury that could persistently impact sleep (e.g., due to immobility), (c) non-fluent in English, (d) previously-diagnosed intellectual disability, autism, bipolar disorder, or psychosis, (e) not attending in-person or virtual school requiring morning attendance, (f) use of medication known to substantially affect sleep (e.g., stimulant).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Concussion; Sleep Wake Disorders

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Dean W Beebe, Ph.D.

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a straightforward two-arm parallel randomized clinical trial with follow-up 1 week and 1 month post-randomization. Eligible adolescents will participate for up to 5 weeks. Week 1 will involve pre-randomization sleep monitoring, and will conclude with a study visit during which staff will review sleep data and give measures of PPCS severity and other outcomes. At that visit, youth who have both PPCS and poor sleep quantity or quality will be evenly randomized to receive the intervention or continue care-as-usual (control). Short-term and extended follow-up assessment will occur in Weeks 2 and 5.

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: February 21, 2023
• Study Start: January 30, 2024
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon publication of primary analyses (or within 2 years of study completion in the unlikely event of no such publication), data will become available. We expect that such access will extend at least 5 years beyond completion of the study.
• Access Criteria: Final Dataset will be provided at no charge to qualified individuals requesting it from the PI.

Locations

US (1)