← Back to Search

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
Must not have
Children who live in a facility without their parent
Children with a tracheostomy or tracheocutaneous fistula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one month
Awards & highlights
No Placebo-Only Group

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.
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).
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a child living in a facility without my parent.
Select...
My child has a tracheostomy or a connection between the trachea and skin.
Select...
My child needs extra oxygen or help to breathe, especially during sleep.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
Secondary study objectives
Child-reported preference between HSAT and PSG
Correlation between OAHI from HSAT and score from OSA questionnaires
Parent-reported acceptability of HSAT
+1 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: 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.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,974 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
24 Previous Clinical Trials
2,770 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 Apnea Research Study Groups: PSG first Participants will be random, HSAT prior to clinical sleep study
Sleep Apnea 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
~17 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top