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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2023
  • participants needed
    10
  • sponsor
    The Hospital for Sick Children
Updated on 24 March 2022
sleep disordered breathing
behavioral problems
sleep-disordered breathing
apnea-hypopnea index
impaired attention

Summary

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.

Details
Condition Sleep Apnea, Central, Prader-Willi Syndrome
Treatment Medical Air vs Oxygen
Clinical Study IdentifierNCT03031626
SponsorThe Hospital for Sick Children
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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