Health Communication for Pediatric Obstructive Sleep Apnea

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Prior OSA diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Health Communication Message for Pediatric Obstructive Sleep Apnea?

Research shows that better education and support can improve adherence to treatments like CPAP for sleep apnea. This suggests that effective health communication can help parents understand and manage their child's sleep apnea treatment more successfully. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

Child is a primary care patient at Eskenazi Health

My child is between 2 and 13 years old.

Parent completed pre-visit questionnaire with OSA screening items

Exclusion Criteria

I have been diagnosed with obstructive sleep apnea.

I was referred for a sleep apnea evaluation in the last two years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Immediately before child's primary care visit

1 visit (in-person)

Intervention

Parents view a health communication message about OSA symptoms before their child's primary care visit

Immediately before child's primary care visit

1 visit (in-person)

Follow-up

Participants are monitored for OSA referrals and evaluations after screening positive for OSA

Up to 12 months

Treatment Details

Interventions

• Health Communication Message

Trial Overview 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.

Participant Groups

Group I: Health Communication Message Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Perceived informational needs, side-effects and their consequences on adherence - a comparison between CPAP treated patients with OSAS and healthcare personnel. [2015]

2. Ireland pubmed.ncbi.nlm.nih.gov

Parental understanding and attitudes of pediatric obstructive sleep apnea and adenotonsillectomy. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of augmented continuous positive airway pressure education and support on compliance and outcome in a Chinese population. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

"It made all the difference": a qualitative study of parental experiences with pediatric obstructive sleep apnea detection. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Polysomnograph chart view by patients: a new educational strategy to improve CPAP adherence in sleep apnea therapy. [2014]