Evidence-based Pediatric Obstructive Sleep Apnea Detection

NCT05908110 | Active Not Recruiting

• 2 other identifiers: 14456K23HL150299-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 9 months after study entry (date of positive OSA screen)

Secondary Outcomes (5)

• Rate of OSA referral

  Up to 3 months after study entry (date of positive screen)

• Rate of Evidence-based Evaluation

  Up to 3 months after study entry (date of positive screen)

• Rate of OSA Diagnosis

  Up to 9 months after study entry (date of positive screen)

• Rate of OSA Treatment

  Up to 12 months after study entry (date of positive screen)

• Rate of Parent Activation

  Immediately after intervention (viewing the Health Communication Message)

Study Arms (2)

Health Communication Message

EXPERIMENTAL

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

Usual Care

NO 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.

Interventions

Health Communication Message BEHAVIORAL

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.

Health Communication Message

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Eskenazi Health: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary care provider will receive the same alert for a positive OSA screen regardless of randomization condition. The primary outcome (OSA referral completion) will be extracted from the medical record by team members who are not aware of the child's randomization status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Participants will be assigned to: 1) intervention (seeing a health communication message about OSA) or 2) Usual care.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 18, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified data will be available 1 year after study completion for a period of 5 years.
• Access Criteria: By investigator request to the PI. Requesting investigator to submit description of research aims and analytic plan.

Locations

US (1)