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Evidence-based Pediatric Obstructive Sleep Apnea Detection

NCT05908110 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-20

No results posted yet for this study

Summary

The goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are:

* Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA?
* Does the use of a health communication message help health care systems identify more children with OSA?

Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist.

In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk).

Researchers will compare groups to see if the health communication message helps identify more children with OSA.

Conditions

  • Obstructive Sleep Apnea of Child

Interventions

BEHAVIORAL

Health Communication Message

The health communication message is a single infographic developed iteratively with input from stakeholders (parents and providers). This image informs the parent that their child may have OSA, lists common nighttime symptoms parents may observe (e.g., snoring, apnea) and common daytime symptoms (e.g., hyperactivity, sleepiness) that can result from OSA. Parents are then encouraged to speak to their child's primary care provider if they observe these symptoms in their child.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Eskenazi Health

    collaborator OTHER

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2027-05-10
Completion
2027-11-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908110 on ClinicalTrials.gov