Clinical trial NCT05736692: Addressing Sleep in Adolescents Post-Concussion ("ASAP Study")
Official title: Addressing Sleep in Adolescents Post-Concussion ("ASAP Study"): A Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Concussion, Brain
Sleep Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Over 500,000 adolescents sustain mild traumatic brain injuries (aka "concussions") in the US each year. Despite the term "mild," concussion symptoms disrupt all aspects of an adolescent's functioning, from school to friendships to family, and impair quality of life. Although many youth recover quickly, \~1/3 still have protracted postconcussive symptoms (PPCS) a month or later post-injury. PPCS are hard to treat medically, as concussion-induced pathophysiology wanes within 1-3 weeks. Instead, contemporary treatments seek to target modifiable patient behaviors that contribute to PPCS. There is accumulating evidence that poor sleep quality or quantity are under-addressed, potent, treatable contributors to PPCS, particularly for adolescents. Indeed, recent studies suggest that targeted behavioral sleep treatments can improve adolescent sleep and other persistent post-concussive symptoms, but published approaches have required 4-6 treatment sessions delivered months post-injury. Such approaches are costly and onerous for families, fit poorly with integrated care models, and leave youth and their families to suffer months of protracted PPCS burden. In contrast, our team has developed a single-session behavioral sleep intervention for adolescents that is designed to be delivered soon after acute pathophysiology wanes (4-7 weeks post-injury) to head off protracted symptom burden. Preclinical and Phase 1 studies suggest that this approach is feasible, well-accepted, and has the potential to improve both sleep and other PPCS. Our long-term plan is to test the effectiveness of that intervention in an applied setting. To justify and guide that large-scale trial, here we propose a Phase 2 clinical trial to definitively test the efficacy of the intervention in a controlled context. We will randomize 70 adolescents aged 12-18 years who are experiencing PPCS and poor sleep quantity or quality to receive either a 1-session sleep treatment (Tx) or care-as-usual (control) 4-7 weeks post-injury. We will assess sleep, PPCS, and real-world functioning just prior to randomization and then again 1 week and 1 month later. Our primary aim is to determine the short-term efficacy of the Tx in improving both sleep and PPCS. Secondarily, we will assess the sustained efficacy of the Tx and its impact on daily functioning. We will also explore potential effect modifiers (e.g., demographics, injury-related factors). To ensure successful completion of this study, we have assembled a team of experts in pediatric brain injury and PPCS, adolescent sleep research, behavioral sleep medicine, and biostatistics with a proven record of successful collaboration, including on similar studies and our Phase 1 trial. The current study represents an important next step in our research program, definitively testing efficacy in a Phase 2 trial prior to embarking on a larger (Phase 3) applied effectiveness study. If, as we propose, our brief intervention both improves sleep and reduces other PPCS, this could lead to a powerful new tool to accelerate the recovery and alleviate burden for hundreds of thousands of adolescents every year.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

(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).

Primary outcomes:
measure: Objective Sleep Assessment
timeFrame: Measured during the week leading up to each of the three study visits
measure: Persistent Post-Concussive Symptom Severity
timeFrame: Measured at all three study visits
measure: Overall Daily Functioning
timeFrame: Measured at all three study visits
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: Dean W Beebe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: