OSA-18 Survey for Mild Obstructive Sleep Apnea
(OSA-18 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byNancy Grover, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Connecticut Children's Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The concept is a novel research idea that incorporates the potential impact of patient quality of life (QOL) on decision-making for treatment of mild obstructive sleep apnea (OSA). Our hypothesis is that in children with mild OSA there is significant conflict with parental decision-making; in the absence of significant sleep apnea, there is limited research regarding comparative efficacy of various treatment options. The impact of a QOL questionnaire can be a significant deciding factor and may help guide management decisions in such situations.

Eligibility Criteria

This trial is for parents or caregivers of children aged 3-12 with mild obstructive sleep apnea (OSA), characterized by an AHI score of 1-5 and tonsillar hypertrophy grade 2 or higher. It's not suitable for those caring for children with syndromic/neurologic conditions, multiple medical issues, or previous tonsillectomy.

Inclusion Criteria

I am a parent or caregiver of a child aged 3 to 12.

My child has mild sleep apnea with an AHI score between 1 and 5.

My child has been diagnosed with significant tonsil enlargement.

Exclusion Criteria

I am the caregiver of a child with a neurological condition or multiple heart or lung issues.

My child has had their tonsils removed.

Participant Groups

The study tests if the OSA-18 Survey, a quality of life questionnaire, can help parents make treatment decisions for their child's mild OSA. The survey aims to reduce decisional conflict by providing insights into how OSA affects the child’s daily life.

2Treatment groups

Experimental Treatment

Active Control

Group I: OSA-18 Case GroupExperimental Treatment2 Interventions

Case group participants will be given the OSA-18 survey at the start of their consultation. OSA-18 is an 18-item questionnaire that collects information about 5 subscales that are considered to be elements in quality of life: sleep disturbance, physical symptoms, emotional symptoms, daytime function, and caregiver concerns. The score is calculated that ranges from 18 (no impact on quality of life) to 126 (major negative impact). Upon completion of OSA-18, scores are tabulated and relayed to families through a decisional aid. The score and the aid, which explains treatment options, risks and benefits will be used to guide discussion throughout the consultation. After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey. All surveys will remain anonymous by using a unique study identifier. Forms will be placed in a locked box by parents prior to departure from the exam room.

Group II: Control GroupActive Control1 Intervention

During the consultation, families will be given a printed form, "decisional aid," which is given to families to explain treatment options as well as their risks and benefits. The consultation will proceed as normal according to standard of care with the aid being used to guide conversation. After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey to complete. All surveys will remain anonymous and only a unique study identification number will be placed on the surveys to correctly match each survey. Forms will be placed in a locked box by parents prior to departure from the exam room.