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Sleep Tests for Pediatric Sleep Apnea (HOM-Kids Trial)

N/A

Recruiting

Led By Christopher M Cielo, DO

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

History of adenotonsillectomy for OSA

Male and female children age 5-12 years old inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one month

Awards & highlights

HOM-Kids Trial Summary

This trial will compare how well two different sleep tests diagnose sleep apnea in children after they've had surgery to remove their tonsils and adenoids.

Who is the study for?

This trial is for boys and girls aged 5-12 who have had surgery to remove their tonsils and adenoids (adenotonsillectomy) to treat sleep apnea. It's not for kids with a tracheostomy, those living without a parent in a facility, or those needing extra oxygen or air pressure during sleep.Check my eligibility

What is being tested?

The study is checking if a home sleep apnea test (HSAT) can accurately tell if children still have obstructive sleep apnea after having their tonsils and adenoids removed, compared to the standard lab test called polysomnography (PSG).See study design

What are the potential side effects?

Since this trial involves diagnostic tests rather than medications, there are no direct side effects from drugs. However, discomfort from wearing testing equipment during sleep may occur.

HOM-Kids Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had surgery to remove my tonsils and adenoids for sleep apnea.

Select...

I am a child aged between 5 and 12 years old.

HOM-Kids Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one month.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one month.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one month. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG

Secondary outcome measures

Child-reported preference between HSAT and PSG

Correlation between OAHI from HSAT and score from OSA questionnaires

Parent-reported acceptability of HSAT

+1 more

HOM-Kids Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HSAT prior to clinical sleep studyExperimental Treatment1 Intervention

Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography

Group II: PSG first Participants will be randomActive Control1 Intervention

Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,760 Total Patients Enrolled

American Academy of Sleep MedicineOTHER

22 Previous Clinical Trials

2,578 Total Patients Enrolled

Christopher M Cielo, DOPrincipal InvestigatorChildren's Hospital of Philadelphia

1 Previous Clinical Trials

317 Total Patients Enrolled

Media Library

Home sleep apnea test Clinical Trial Eligibility Overview. Trial Name: NCT05516524 — N/A

Sleep Disorder Research Study Groups: PSG first Participants will be random, HSAT prior to clinical sleep study

Sleep Disorder Clinical Trial 2023: Home sleep apnea test Highlights & Side Effects. Trial Name: NCT05516524 — N/A

Home sleep apnea test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05516524 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals over the age of 35 participate in this research initiative?

"This research project is targeting participants between the ages of 5 and 12 years old."

Answered by AI

Are there still openings available to participate in this research?

"Data on clinicaltrials.gov states that this particular trial, which was initially disclosed November 1st 2022 and recently edited October 14th 2022, is not actively recruiting at the moment. Nevertheless, there are 458 other active trials in search of candidates."

Answered by AI

Is it possible to enroll in this clinical experiment?

"In this sleep apnea study, 60 children aged 5 to 12 can be recruited. To qualify for the trial, these individuals must have undergone a adenotonsillectomy and meet the gender criteria specified by our team of researchers."

Answered by AI