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

N/A

Recruiting

Led By Nancy Grover, MD

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parent/caregiver of child who has been diagnosed with tonsillar hypertrophy grade 2 or higher

Be younger than 18 years old

Must not have

Parent/caregiver of child diagnosed with a syndromic or known neurologic condition and/or multiple (more than two) medical cardiac or respiratory medical conditions

Parent/caregiver of child who has previously underwent tonsillectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, and average of 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks into the effect of patient quality of life on mild obstructive sleep apnea treatment decisions; QOL could help make these decisions easier.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a survey rather than medication or surgery, there are no direct physical side effects. However, discussing health-related quality of life could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has been diagnosed with significant tonsil enlargement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My child has had their tonsils removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, and average of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, and average of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, and average of 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decisional Conflict Scale (DCS)

Secondary study objectives

Age of child and parent/legal guardian

BMI Z-score

BMI percentile

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met