Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
HATCH Trial 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.Check my eligibility
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.See study design
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.
HATCH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a child aged between 5 and 12 years old.
HATCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Polysomnography
Secondary outcome measures
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
HATCH 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
901 Previous Clinical Trials
409,669 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,540 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,580,690 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a tracheostomy or a connection between the trachea and skin.My child had a sleep study within the last 3 years.I am a child living in a facility without my parent.My child needs extra oxygen or help to breathe, especially during sleep.I am a child aged between 5 and 12 years old.
Research Study Groups:
This trial has the following groups:- Group 1: HSAT first
- Group 2: PSG first
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.
Who is eligible to partake in this clinical trial?
"The recruiting criteria for this trial dictate that potential participants must be diagnosed with a sleep apnea syndrome, and lie within the age range of 5 to 12. At present, 317 candidates are being sought after."
Answered by AI
Are participants of this clinical trial required to be over 25 years old?
"According to the specified eligibility criteria, suitable candidates for this trial must be aged between 5 and 12. Additionally, there are 83 trials open for patients below 18 years old and 350 studies recruiting seniors over 65."
Answered by AI
Are there currently open positions for this research endeavor?
"From what is available on clinicaltrials.gov, enrollment for this medical trial appears to be closed at the moment. The study was first posted in April of 2023 and last updated in August 2022. Although no longer recruiting participants, there are 458 other trials actively looking for volunteers right now."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger