Comparing oxygen and medical air for treating central sleep apnea in infants with Prader-Willi Syndrome

Comparison of Therapeutic Oxygen Versus Medical Air for the Treatment of Central Sleep Apnea in Infants and Children With Prader Willi Syndrome: A Proof of Concept Study

This study is testing whether using medical air can help infants with Prader-Willi Syndrome and central sleep apnea just as well as using supplemental oxygen.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: N/A to 2 Years
• Sex: All
• Sponsor: The Hospital for Sick Children (other)
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT03031626 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of medical air versus supplemental oxygen in improving the central apnea-hypopnea index (CAHI) in infants diagnosed with Prader-Willi Syndrome. The research focuses on infants under two years old who have been referred for sleep evaluation and found to have significant central sleep apnea. By comparing these two treatments, the study seeks to understand if medical air can provide similar benefits as 100% oxygen. The hypothesis is based on the potential arousal stimulus effect of medical air on the hypothalamus and the role of oxygen in treating central sleep apnea.

Who should consider this trial

Good fit: Ideal candidates are infants under two years old with genetically confirmed Prader-Willi Syndrome and clinically significant central sleep apnea.

Not a fit: Patients who may not benefit include those with concurrent conditions causing sleep-disordered breathing or those requiring daytime supplemental oxygen.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for infants with Prader-Willi Syndrome suffering from central sleep apnea.

How similar studies have performed: While there is ongoing research into central sleep apnea treatments, this specific comparison of medical air and oxygen in Prader-Willi Syndrome is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. infants under age two with genetically confirmed Prader-Willi Syndrome
2. referred to HSC sleep clinic for evaluation with polysomnogram prior to initiation of growth hormone
3. infants found to have clinically significant central sleep apnea, defined as an apnea-hypopnea index (AHI) equal to or greater than 5

Exclusion Criteria:

1. infants delivered prematurely (less than 37 weeks gestational age)
2. term infants with a history of hypoxic-ischemic encephalopathy or stroke
3. any concurrent diagnoses that may cause sleep-disordered breathing (ie. craniofacial abnormalities, arnold-chiari malformation, etc)
4. infants with a need for daytime supplemental oxygen (ie. cardiac anomalies)
5. infants found to have low baseline oxygen saturations on PSG

Where this trial is running

Toronto, Ontario and 1 other locations

• The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
• The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)

Conditions: Sleep Apnea, Central, Prader-Willi Syndrome