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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a health communication message helps parents recognize obstructive sleep apnea (OSA) symptoms in their children and discuss them with health care providers. Researchers seek to discover whether an infographic about OSA leads to more evaluations and diagnoses in children. The trial compares parents who view the infographic to those who do not, assessing which group identifies more OSA cases. Parents with children aged 2 to 13 who frequently snore, exhibit other OSA signs like daytime sleepiness, and have not been previously diagnosed with OSA may be suitable for this trial. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could enhance early diagnosis and treatment of OSA in children.

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 prior data suggests that this health communication message is safe for children with OSA symptoms?

Research shows that information about pediatric obstructive sleep apnea (OSA) is well-received by both parents and healthcare providers. One study rated the information highly for accuracy and ease of acceptance. Sleep specialists gave it a perfect score for accuracy, and primary care doctors found it very acceptable. This indicates that the information is clear and trustworthy.

No reports of negative effects exist because the treatment is purely educational, not a medication or medical procedure. The goal is to teach parents about OSA symptoms, aiding in the identification of children who may need further evaluation.

This non-invasive, educational approach is considered very safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh approach to managing pediatric obstructive sleep apnea (OSA) through health communication. Unlike typical treatments that focus on surgical options like tonsillectomy or medical interventions like CPAP machines, this method emphasizes early detection and parental involvement. The unique feature of this approach is the use of a health communication message, an infographic, that educates parents about OSA symptoms, prompting them to discuss these concerns with a healthcare provider. This proactive communication strategy aims to identify and address OSA symptoms early, potentially improving outcomes without immediate reliance on traditional medical or surgical interventions.

What evidence suggests that this health communication message is effective for identifying pediatric obstructive sleep apnea?

This trial will compare the effectiveness of a health communication message with usual care in helping parents identify signs of obstructive sleep apnea (OSA) in their children. Research has shown that clear health messages can help parents spot signs of OSA. In this trial, one group of parents will review an infographic designed to teach them about OSA symptoms that occur both at night and during the day, encouraging them to talk to their child's doctor about these symptoms. Previous research suggests that this kind of focused communication can increase parental involvement, leading to more conversations with healthcare providers. This may help identify OSA in children sooner, allowing for better treatment. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05908110

Evidence-based Pediatric Obstructive Sleep Apnea Detection 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/10685509

Evidence-based Detection of Pediatric Obstructive Sleep Apnea The overall objective of this research is to: (i) to develop a health communication message that actively engages parents by informing them of their child's ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9340584/

“It made all the difference”: a qualitative study of parental ... Parental experiences highlight aspects of the health care system that are both effective and ineffective in detecting children with OSA.

4. academic.oup.com academic.oup.com/sleep/article/45/Supplement_1/A233/6592874

0528 Development of Pediatric OSA Health Communication ... We developed a health communication message in the form of an infographic, designed to help parents recognize the link between nighttime and ...

5. researchgate.net researchgate.net/publication/360988089_0528_Development_of_Pediatric_OSA_Health_Communication_Messaging_for_and_with_Parents

0528 Development of Pediatric OSA Health ... To activate parents to talk to their child's provider about OSA symptoms, there is a need for effective OSA health communication messaging.

6. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10024

a qualitative study of parental experiences with pediatric ... Parental experiences highlight aspects of the health care system that are both effective and ineffective in detecting children with OSA.