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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
Must not have
Prior OSA diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after study entry (date of positive screen)
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with obstructive sleep apnea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months after study entry (date of positive screen)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after study entry (date of positive screen)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Completed OSA referral
Secondary study objectives
Rate of Evidence-based Evaluation
Rate of OSA Diagnosis
Rate of OSA Treatment
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,040 Previous Clinical Trials
1,219,864 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,792,098 Total Patients Enrolled
Eskenazi HealthOTHER
13 Previous Clinical Trials
3,522 Total Patients Enrolled