Evidence-based Pediatric Obstructive Sleep Apnea Detection

The Role of Health Communication Messaging in Evidence-based Pediatric Obstructive Sleep Apnea Detection

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea of Child
• Intervention / Treatment: Behavioral: Health Communication Message

Detailed Description

Many children with obstructive sleep apnea (OSA) are not identified and thus do not receive treatment. In a previous study, the investigators found that a clinical decision support system helped primary care providers (PCPs) identify children with obstructive sleep apnea (OSA). In this system, parents of children report on possible OSA symptoms (e.g., snoring, sleepiness) in their child before the visit. If the child has OSA symptoms, the PCP receives an alert during the visit recommending further evaluation and a possible referral for a sleep study or to see a specialist. While this system helped increase the number of children with OSA symptoms who received a referral, many children remained unidentified. The goal of this study is to see whether involving parents in the system can identify even more children.

In this study, the investigators propose to test the impact of a health communication message, designed to educate and activate parents about their child's risk for OSA. This message is an infographic that helps parents recognize nighttime symptoms of OSA and how these nighttime symptoms may be impacting their child during the day. If a child has OSA symptoms, parents would view this infographic before their child's PCP visit and could discuss OSA with their child's PCP. For children with OSA symptoms, their parents will be randomized to either: 1) view the health communication message, or; 2) usual care, in which parents are not given any additional information about OSA or their child's risk prior to the appointment. In both cases, PCPs will receive a prompt indicating that the child is at risk for OSA.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Child ages 2.0-13.9 years at the time of OSA screening.
• Child is a primary care patient at Eskenazi Health
• Parent completed pre-visit questionnaire with OSA screening items
• Child screened positive for OSA (snoring >= 3 nights/wk + 1 additional symptom)

Exclusion Criteria:

• Prior OSA diagnosis
• Prior OSA referral (ENT, PSG, Sleep medicine) in the past two years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Communication Message; 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.	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.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Completed OSA referral	Rate of children who received and completed (e.g., attended appointment or sleep study) a referral for sleep-disordered breathing, amongst those who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.	Up to 12 months after study entry (date of positive OSA screen)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of OSA referral	Rate of children who received referral for sleep-disordered breathing, amongst whose who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.	Up to 3 months after study entry (date of positive screen)
Rate of Evidence-based Evaluation	Rate of child who received evidence-based evaluation for pediatric OSA, amongst those who screened positive for OSA. Evidence-based evaluation includes 1) OSA referral; 2) documented watchful waiting with follow-up plan; and/or 3) documentation of evaluation not consistent with sleep-disordered breathing.	Up to 3 months after study entry (date of positive screen)
Rate of Parent Activation	Rate of parents who report planning to speak with child's provider about OSA, amongst those who viewed the health communication message. This will be measured by parental response to an item asking if they plan to speak with their child's provider about OSA, presented at the time that the parent reviews the health communication message.	Immediately after intervention (viewing the Health Communication Message)
Rate of OSA Diagnosis	Rate of children who received an OSA diagnosis (verified via polysomnogram; apnea hypopnea index >1.5), amongst those who screened positive for OSA.	Up to 12 months after study entry (date of positive screen)
Rate of OSA Treatment	Rate of children receiving OSA treatment, amongst those who screened positive for OSA. Treatment to include 1) surgical intervention; 2) CPAP; 3) dental device; and/or 4) medication.	Up to 18 months after study entry (date of positive screen)

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Eskenazi Health

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): November 10, 2027

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 14456, 31533; K23HL150299-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share data consistent with the requirements of the funder (NHLBI) and my institution.
• IPD Sharing Time Frame: Deidentified data will be available 1 year after study completion for a period of 5 years.
• IPD Sharing Access Criteria: By investigator request to the PI. Requesting investigator to submit description of research aims and analytic plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No