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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03031626
Other study ID # 1000053577
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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