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Home vs Lab Sleep Apnea Testing for Sleep Apnea (HATCH 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
Male and female children age 5-12 years old inclusive
Be younger than 18 years old
Must not have
Children with a tracheostomy or tracheocutaneous fistula
Children who live in a facility without their parent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare home sleep apnea testing to in-lab polysomnography to see which is more accurate, leads to better decisions about treatment, and is more acceptable to parents and children.

Who is the study for?
This trial is for children aged 5-12 who are being checked for sleep apnea at the Children's Hospital of Philadelphia. They need consent from a parent or guardian, and if old enough, their own agreement to participate. Kids living without parents, with breathing holes in their necks (tracheostomy), serious breathing problems during sleep, or recent sleep studies can't join.
What is being tested?
The study is looking at how well home sleep tests work compared to overnight stays at the hospital lab where they watch your child's sleep closely (polysomnography). It checks which method tells us more accurately about sleep issues, helps doctors decide on treatment better, and what kids and parents prefer.
What are the potential side effects?
There aren't any direct side effects mentioned for participating in this trial since it involves diagnostic procedures rather than medications. However, there might be some discomfort or inconvenience associated with wearing testing equipment during sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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...
My child has a tracheostomy or a connection between the trachea and skin.
Select...
I am a child living in a facility without my parent.
Select...
My child needs extra oxygen or help to breathe, especially during sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Polysomnography
Secondary study objectives
Association between therapeutic decision from HSAT compared to PSG
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Proportion of participants who prefer HSAT to PSG

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 firstExperimental Treatment1 Intervention
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Group II: PSG firstActive 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?

University of MiamiOTHER
955 Previous Clinical Trials
428,536 Total Patients Enrolled
1 Trials studying Sleep Apnea
330 Patients Enrolled for Sleep Apnea
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,512 Total Patients Enrolled
16 Trials studying Sleep Apnea
5,558 Patients Enrolled for Sleep Apnea
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,002 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,303 Total Patients Enrolled
1 Trials studying Sleep Apnea
54 Patients Enrolled for Sleep Apnea
Christopher M Cielo, DOPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Home sleep apnea test Clinical Trial Eligibility Overview. Trial Name: NCT05382754 — N/A
Sleep Apnea Research Study Groups: HSAT first, PSG first
Sleep Apnea Clinical Trial 2023: Home sleep apnea test Highlights & Side Effects. Trial Name: NCT05382754 — N/A
Home sleep apnea test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05382754 — N/A
~166 spots leftby Dec 2026
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