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Brief Sleep Intervention for Concussion

Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Concussion+1 More ConditionsBrief Sleep Intervention - Behavioral
Eligibility
13 - 18
All Sexes

Study 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

Eligible Conditions
  • Concussion
  • Sleep Disorders

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Measured during the week leading up to each of the three study visits

Measured at all three study visits
Overall Daily Functioning
Persistent Post-Concussive Symptom Severity
Measured during the week leading up to each of the three study visits
Objective Sleep Assessment

Trial Safety

Phase-Based Safety

1 of 3

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1
EV-Pure™ and WJ-Pure™ plus standard care
1
EV-Pure™ and WJ-Pure™
2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control
1 of 2
Brief Sleep Intervention
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Brief Sleep Intervention · No Placebo Group · N/A

Brief Sleep Intervention
Behavioral
Experimental Group · 1 Intervention: Brief Sleep Intervention · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief Sleep Intervention
2013
N/A
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured during the week leading up to each of the three study visits

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
772 Previous Clinical Trials
5,425,823 Total Patients Enrolled
Dean W Beebe, Ph.D.Principal InvestigatorCincinnati Children's
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 13 - 18 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are experiencing ongoing concussion symptoms and have trouble sleeping.
You had a head injury that caused symptoms lasting for at least 3-6 weeks before the start of the study.
You sleep less than 8 hours a night or have trouble falling asleep or staying asleep for at least 85% of the time you are in bed. You also report poor sleep quality with a score higher than 5 on a sleep quality index.
References

Frequently Asked Questions

Are participants aged 80 and younger being included in this experiment?

"This clinical investigation is seeking participants aged between 13 and 18 years old." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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