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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, and average of 3 months
Awards & highlights
OSA-18 Trial 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.Check my eligibility
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.See study design
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.
OSA-18 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has been diagnosed with significant tonsil enlargement.
OSA-18 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decisional Conflict Scale (DCS)
Secondary outcome measures
Age of child and parent/legal guardian
BMI Z-score
BMI percentile
+8 moreOSA-18 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.
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Who is running the clinical trial?
Connecticut Children's Medical CenterLead Sponsor
71 Previous Clinical Trials
31,384 Total Patients Enrolled
ResMed FoundationOTHER
14 Previous Clinical Trials
1,505 Total Patients Enrolled
Nancy Grover, MDPrincipal InvestigatorConnecticut Children's Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: OSA-18 Case Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count of this clinical trial?
"Affirmative. Per the clinicaltrials.gov database, this medical trial is currently enrolling patients and was initially published on June 2nd 2021 with a recent update recorded on June 20th 2021. The study plans to include 130 individuals across 1 site."
Answered by AI
Who is eligible to enroll in this research initiative?
"This clinical trial is accepting up to 130 participants that are between 3 and 12 years old, suffering from obstructive sleep apnea."
Answered by AI
Is this research study open to participants who are of advanced age?
"Applicable candidates for this trial must be between 3 and 12 years old, with a total of 44 studies being conducted on minors and 204 trials devoted to senior citizens."
Answered by AI
Are there any openings for individuals to partake in this experimental trial?
"According to the information recorded on clinicaltrials.gov, this trial is actively enrolling participants and has been since June 2nd 2021. The details of this study have most recently been updated as of June 20th 2023."
Answered by AI
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