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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)

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

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 more

Awards & 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.

0 / 1Eligibility criteria met