Evidence-based Pediatric Obstructive Sleep Apnea Detection

Obstructive Sleep Apnea of Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05908110
• Other study ID #: 14456
• Secondary ID: K23HL150299-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Child
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Eskenazi Health, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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 9 months after study entry (date of positive screen)
Secondary	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 12 months after study entry (date of positive screen)
Secondary	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)