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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary outcome measures

Delta CAHI1

Delta CAHI2

Difference in CAHI1 and CAHI2

Secondary outcome measures

Arousal Index1

Arousal Index2

Desaturation Index1

+1 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

691 Previous Clinical Trials

6,945,594 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

Frequently Asked Questions

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

Are there still opportunities for individuals to participate in this research study?

"Indeed, the information available on clinicaltrials.gov demonstrates that this medical research project is recruiting patients at present. Initially published on September 1st 2016 and most recently updated October 24th 2022, it requires 10 individuals from a single location to participate."

Answered by AI

How many participants are receiving treatment in this trial?

"Affirmative. The information available on clinicaltrials.gov displays that this medical research is currently seeking participants, which was initially posted in September 1st 2016 and modified lastly in October 24th 2022. There are 10 patients needed from one center for further investigation."

Answered by AI

What is the overarching aim of this experimental research?

"This trial will monitor two primary performance metrics, CAHI1 and Arousal Index1 over the course of two years. Additionally, Desaturation Index2 and Delta Arousal Index are also being assessed as secondary indicators to measure efficacy."

Answered by AI

Does the Food and Drug Administration certify Medical Air or Oxygen for therapeutic use?

"There is ample evidence of Medical Air's safety, prompting it to receive a score of 3 on our scale. This evaluation was taken from the Phase 4 trial results which indicate its approval for use."

Answered by AI