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

Prader-Willi Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031626
• Other study ID #: 1000053577
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: December 15, 2024

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Syndrome

Intervention

Biological:
• Medical Air vs Oxygen
Medical Air/Oxygen will be given

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta CAHI1	Difference in CAHI at baseline compared to supplemental oxygen Delta CAHI1: CAHIoxygen - CAHIbaseline	2 years
Primary	Delta CAHI2	Difference in CAHI at baseline compared to medical air Delta CAHI2: CAHImedical air - CAHIbaseline	2 years
Primary	Difference in CAHI1 and CAHI2	A comparison of change in CAHI1 and change in CAHI2 DeltaCAHI1: DeltaCAHI2	2 years
Secondary	Arousal Index1	Difference in Arousal Index at baseline compared to medical air Delta Arousal Index: Arousal Indexmedical air - Arousal Indexbaseline	2 years
Secondary	Arousal Index2	Difference in Arousal Index at baseline compared to Supplemental oxygen Delta Arousal Index: Arousal Indexoxygen - Arousal Indexbaseline	2 years
Secondary	Desaturation Index1	Difference in Desaturation Index at baseline compared to medical air Delta Arousal Index: Desaturation Indexmedical air - Desaturation Indexbaseline	2 years
Secondary	Desaturation Index2	Difference in Desaturation Index at baseline compared to supplemental oxygen Delta Arousal Index: Desaturation Indexoxygen - Desaturation Indexbaseline	2 years