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Completed

NCT Number: NCT03031626

Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome

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.

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Key information

Conditions

Sleep Apnea, Central Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Prader-Willi Syndrome Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Medical Air vs Oxygen

Biological

Medical Air/Oxygen will be given

Primary outcomes

  1. Delta CAHI1

    Time frame: 2 years

    Difference in CAHI at baseline compared to supplemental oxygen Delta CAHI1: CAHIoxygen - CAHIbaseline

  2. Delta CAHI2

    Time frame: 2 years

    Difference in CAHI at baseline compared to medical air Delta CAHI2: CAHImedical air - CAHIbaseline

  3. Difference in CAHI1 and CAHI2

    Time frame: 2 years

    A comparison of change in CAHI1 and change in CAHI2 DeltaCAHI1: DeltaCAHI2

Secondary outcomes

  1. Arousal Index1

    Time frame: 2 years

    Difference in Arousal Index at baseline compared to medical air Delta Arousal Index: Arousal Indexmedical air - Arousal Indexbaseline

  2. Arousal Index2

    Time frame: 2 years

    Difference in Arousal Index at baseline compared to Supplemental oxygen Delta Arousal Index: Arousal Indexoxygen - Arousal Indexbaseline

  3. Desaturation Index1

    Time frame: 2 years

    Difference in Desaturation Index at baseline compared to medical air Delta Arousal Index: Desaturation Indexmedical air - Desaturation Indexbaseline

  4. Desaturation Index2

    Time frame: 2 years

    Difference in Desaturation Index at baseline compared to supplemental oxygen Delta Arousal Index: Desaturation Indexoxygen - Desaturation Indexbaseline

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2017
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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