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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 February 2021
Main ID:  NCT03031626
Date of registration: 20/01/2017
Prospective Registration: No
Primary sponsor: The Hospital for Sick Children
Public title: Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome
Scientific 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
Date of first enrolment: September 1, 2016
Target sample size: 10
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03031626
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Canada
Contacts
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 2 Years
Gender: All
Health Condition(s) or Problem(s) studied
Prader-Willi Syndrome
Sleep Apnea, Central
Intervention(s)
Biological: Medical Air vs Oxygen
Primary Outcome(s)
Delta CAHI1 [Time Frame: 2 years]
Delta CAHI2 [Time Frame: 2 years]
Difference in CAHI1 and CAHI2 [Time Frame: 2 years]
Secondary Outcome(s)
Arousal Index1 [Time Frame: 2 years]
Arousal Index2 [Time Frame: 2 years]
Desaturation Index1 [Time Frame: 2 years]
Desaturation Index2 [Time Frame: 2 years]
Secondary ID(s)
1000053577
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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