Medical Air vs Oxygen for Prader-Willi Syndrome

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: The Hospital for Sick Children

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine if treatment with Medical Air (21% oxygen in room air) compared to supplemental oxygen (100% oxygen) will lead to similar improvements in the central apnea-hypopnea index (CAHI) for infants with Prader-Willi Syndrome. Despite the vast amount of research investigating the cause of central sleep apnea, there remain gaps in knowledge, lending to further research efforts. The decision to compare oxygen to medical air is based on several theorized mechanisms. The first of which is the supposition that provision of medical air may act as an arousal stimulus for the hypothalamus, thereby preventing sleep disordered breathing. Secondly, the hypercapnic challenge performed by Livingston et al demonstrated a delayed hypercapneic arousal response in PWS subjects despite simultaneous hyperoxia, leading us to question if therapeutic oxygen really plays a significant role in treating CSA. Lastly, the delivery of medical air via nasal prongs may provide sufficient arousal to terminate the cycle of events leading to central apnea, as described by Urquhart et al. A deeper understanding of central sleep apnea is essential to ameliorating its adverse sequelae, which include symptoms of ADHD, impaired attention, behavioral problems, and academic difficulties.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My infant has significant sleep apnea, with an AHI of 5 or more.

My child under 2 has Prader-Willi Syndrome and is referred for a sleep study before starting growth hormone.

Exclusion Criteria

Babies born too early (before 37 weeks of pregnancy)

My infant needs extra oxygen during the day due to heart issues.

I do not have conditions that could affect my breathing during sleep.

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Treatment Details

Interventions

Medical Air vs Oxygen ()

Trial OverviewThe 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.

Participant Groups

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