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Health Communication for Pediatric Obstructive Sleep Apnea

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after study entry (date of positive screen)
Awards & highlights

Study Summary

This trial tests whether a health communication message can help parents of kids with OSA symptoms to talk to their providers and identify more children with OSA. Parents and kids with OSA symptoms will be randomly assigned to one of two groups.

Who is the study for?
This trial is for parents of children aged 2-13.9 years who are patients at Eskenazi Health and show signs of obstructive sleep apnea, like snoring more than three nights a week plus another symptom. Children already diagnosed with OSA or referred for OSA treatment in the past two years can't participate.Check my eligibility
What is being tested?
The study tests if an infographic about obstructive sleep apnea shown to parents helps them discuss their child's symptoms with doctors, leading to better identification of OSA in kids. Parents answering screening questions will be randomly assigned to see the message or receive usual care.See study design
What are the potential side effects?
Since this intervention involves health communication without direct medical treatment, there are no physical side effects expected from viewing the health message.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after study entry (date of positive screen)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months after study entry (date of positive screen) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Completed OSA referral
Secondary outcome measures
Rate of Evidence-based Evaluation
Rate of OSA Diagnosis
Rate of OSA Treatment
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Health Communication MessageExperimental Treatment1 Intervention
Parents will review a health communication message (infographic) informing them that their child has OSA symptoms, describing both nighttime and daytime OSA symptoms, and encouraging them to speak to their child's primary care provider at the scheduled visit if they observe symptoms in their child. Primary care providers will receive an alert that the child screened positive for OSA.
Group II: Usual CareActive Control1 Intervention
Like in the intervention group, parents will complete screening items and primary care providers will receive an alert if the child screens positive for OSA. However, parents randomized to this condition will not view the health communication message nor receive any information about OSA or their child's risk for OSA.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,961 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,435 Total Patients Enrolled
Eskenazi HealthOTHER
11 Previous Clinical Trials
2,634 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to participate in this experiment?

"This medical study, which was initially advertised on June 23rd 2023 and last refreshed on the 8th of that month is no longer enrolling patients. However, 251 other trials are still actively searching for participants at this moment in time."

Answered by AI

Is the cutoff age for this clinical trial below 20 years of age?

"Participants for this scientific investigation must be between two and thirteen years of age."

Answered by AI

Am I able to participate in the research endeavor?

"To qualify for the trial, patients must meet two criteria: they have to be diagnosed with obstructive sleep apnea and fall within a specified age range of 2-13 years old. The research team is hoping to recruit 200 subjects in total."

Answered by AI

Who else is applying?

What site did they apply to?
Indiana University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~67 spots leftby Oct 2024