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Sleep Intervention for Post-Concussion Recovery in Adolescents (ASAP Trial)
N/A
Waitlist Available
Led By Dean W Beebe, Ph.D.
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PPCS will be defined as: concussion resulting in >1 new symptom on the Post-Concussion Symptom Scale that persists 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at all three study visits
Awards & highlights
ASAP Trial Summary
This trial will evaluate a promising treatment to help adolescents recover faster from concussion, reducing the burden on families, society, and the youth. #concussion #research
Who is the study for?
The ASAP Study is for adolescents who had a concussion with symptoms persisting 3-6 weeks post-injury. They must have sleep issues and be experiencing persistent post-concussive symptoms. Excluded are those with severe brain injuries, incomplete recovery from previous mTBIs, non-English speakers, irregular school attendance, certain medication use, or pre-existing conditions like intellectual disability or autism.Check my eligibility
What is being tested?
This study tests a brief behavioral intervention aimed at improving sleep in adolescents recovering from concussions. It seeks to determine if better sleep can reduce the long-term impact of concussion symptoms by providing an accessible treatment that fits into existing care models.See study design
What are the potential side effects?
Since this trial involves a behavioral sleep intervention rather than medication, side effects may be minimal and could include temporary changes in mood or behavior due to adjustments in sleeping patterns.
ASAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have new symptoms from a concussion that have lasted more than 4 weeks.
Select...
I either sleep less than 8 hours on school nights or feel my sleep quality is poor.
ASAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured during the week leading up to each of the three study visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during the week leading up to each of the three study visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Sleep Assessment
Overall Daily Functioning
Persistent Post-Concussive Symptom Severity
ASAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Sleep InterventionExperimental Treatment1 Intervention
1-session intervention designed to improve adolescent sleep quality and/or quantity.
Group II: ControlActive Control1 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief Sleep Intervention
2013
N/A
~60
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,596 Total Patients Enrolled
Dean W Beebe, Ph.D.Principal InvestigatorCincinnati Children's
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with intellectual disability, autism, bipolar disorder, or psychosis in the past.I have ongoing symptoms from a concussion and trouble sleeping.I either sleep less than 8 hours on school nights or feel my sleep quality is poor.I have had a severe brain injury or a mild one I haven't fully recovered from.I had a brain injury with a GCS score below 13 or abnormal brain scans.I am not fluent in English.I am taking medication that significantly affects my sleep.I have an injury outside my brain that affects my sleep due to difficulty moving.You recently had a head injury and still have symptoms 3-6 weeks later.I have new symptoms from a concussion that have lasted more than 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Brief Sleep Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 80 and younger being included in this experiment?
"This clinical investigation is seeking participants aged between 13 and 18 years old."
Answered by AI
Is there an opportunity to partake in this research?
"Patients experiencing concussion, aged between 13 and 18 years old, can apply to this trial. There is an estimated requirement of 100 participants for the duration of the study."
Answered by AI
Are researchers still enrolling participants in this experiment?
"It appears that, as of 2/11/2023, this particular trial is no longer recruiting. The initial posting date was 3/1/2023. Despite not currently requiring patients, there are still 183 other trials actively enrolling individuals at the present time."
Answered by AI
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