NCT03031626CompletedPhase 4
Oxygen Versus Medical Air for Treatment of CSA in Prader Will 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
Source: ClinicalTrials.gov · Last updated 8 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 20 Jan 2017
- Start date
- 1 Sept 2016
- Primary completion date
- 15 Mar 2025
- Lead sponsor
- The Hospital for Sick Children
- NCT number
- NCT03031626
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 9
- From 1 Sept 2016 to the primary completion date, 15 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- any concurrent diagnoses that may cause sleep-disordered breathing (ie. craniofacial abnormalities, arnold-chiari malformation, etc)
Other illness
- term infants with a history of hypoxic-ischemic encephalopathy or stroke
- infants with a need for daytime supplemental oxygen (ie. cardiac anomalies)
Age
- infants delivered prematurely (less than 37 weeks gestational age)
Other
- infants found to have low baseline oxygen saturations on PSG
Who the study is looking for
- infants under age two with genetically confirmed Prader-Willi Syndrome
- referred to HSC sleep clinic for evaluation with polysomnogram prior to initiation of growth hormone
- infants found to have clinically significant central sleep apnea, defined as an apnea-hypopnea index (AHI) equal to or greater than 5
Age in the registry: - to 2 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.