← Back to Search

Medical Air vs Oxygen for Prader-Willi Syndrome

Phase 4
Recruiting
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants found to have clinically significant central sleep apnea, defined as an apnea-hypopnea index (AHI) equal to or greater than 5
Be younger than 18 years old
Must not have
Infants with a need for daytime supplemental oxygen (i.e. cardiac anomalies)
Term infants with a history of hypoxic-ischemic encephalopathy or stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare medical air to supplemental oxygen in the treatment of central sleep apnea in infants with Prader-Willi Syndrome.

Who is the study for?
This trial is for infants under two years old with Prader-Willi Syndrome who have significant central sleep apnea but no other conditions that could affect breathing, like craniofacial abnormalities. They shouldn't need daytime oxygen or have had a stroke, and must be full-term babies.
What is being tested?
The study tests if Medical Air (normal air) can improve central sleep apnea in these infants as effectively as pure Oxygen does. It's based on the idea that medical air might stimulate the brain during sleep better than oxygen.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing nasal prongs and possible skin irritation. The risk of lung or eye damage from high oxygen levels should also be considered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My infant has significant sleep apnea, with an AHI of 5 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant needs extra oxygen during the day due to heart issues.
Select...
My baby had a stroke or brain injury due to lack of oxygen at birth.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Delta CAHI1
Delta CAHI2
Difference in CAHI1 and CAHI2
Secondary study objectives
Arousal Index1
Arousal Index2
Desaturation Index1
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Oxygen followed by medical airExperimental Treatment1 Intervention
Group II: Arm A: Medical air followed by oxygenExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
710 Previous Clinical Trials
6,958,186 Total Patients Enrolled

Media Library

Central Sleep Apnea Research Study Groups: Arm A: Medical air followed by oxygen, Arm B: Oxygen followed by medical air
~0 spots leftby Dec 2024
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