Oxygen Versus Medical Air for Treatment of CSA in Prader... | NCT03031626

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

NCT03031626

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Jun 8, 2025Actual

Enrollment

9Actual

Phase

Phase 4

Conditions

Sleep Apnea, Central
Prader-Willi Syndrome

Interventions

Medical Air vs Oxygen

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Mar 15, 2025Actual

Completion Date

Mar 15, 2025Actual

First Submitted Date

Jan 20, 2017

First Submission Date that Met QC Criteria

Jan 23, 2017

First Posted Date

Jan 25, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reshma Amin, Respirologist, Clinician Investigator, The Hospital for Sick ChildrenPrincipal Investigator

Lead Sponsor

The Hospital for Sick ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Medical air followed by oxygen	Experimental		Biological: Medical Air vs Oxygen
Arm B: Oxygen followed by medical air	Experimental		Biological: Medical Air vs Oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Air vs Oxygen	Biological	Medical Air/Oxygen will be given	Arm A: Medical air followed by oxygen Arm B: Oxygen followed by medical air

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delta CAHI1	Difference in CAHI at baseline compared to supplemental oxygen Delta CAHI1: CAHIoxygen - CAHIbaseline	2 years
Delta CAHI2	Difference in CAHI at baseline compared to medical air Delta CAHI2: CAHImedical air - CAHIbaseline	2 years
Difference in CAHI1 and CAHI2	A comparison of change in CAHI1 and change in CAHI2 DeltaCAHI1: DeltaCAHI2	2 years

Secondary Outcomes

Measure	Description	Time Frame
Arousal Index1	Difference in Arousal Index at baseline compared to medical air Delta Arousal Index: Arousal Indexmedical air - Arousal Indexbaseline	2 years
Arousal Index2	Difference in Arousal Index at baseline compared to Supplemental oxygen Delta Arousal Index: Arousal Indexoxygen - Arousal Indexbaseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reshma Amin, MD	The Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020182	Sleep Apnea, Central
D011218	Prader-Willi Syndrome

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The screening visit will occur during a regularly scheduled clinic visit. The patients that have consented for the study will all undergo the baseline PSG. Only patients with clinically significant CSA after Visit 1 will undergo randomization and complete Visit 2.

Those who have a CAHI greater or equal to 5 will be randomly assigned to Arm A or Arm B. Randomization will be performed using a computer with random numbers drawn. Arm A will receive Medical Air followed by Oxygen and Arm B will receive Oxygen followed by Medical Air.

Masking Info

Masking

Triple

Masking Description

The split-night polysomnograms (Arm A, Arm B) will be scored by a blinded independent sleep technologist. A Sleep Physician will report the sleep study and be blinded as to the gas assignment (ie Arm A or Arm B).

Who Masked

Care ProviderInvestigatorOutcomes Assessor