Trials Sponsors Conditions Drugs Pricing

Conditions

Prader-Willi Syndrome Sleep Apnea, Central

Outcome Measures

Primary Outcomes (3)

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 (4)

Arousal Index1
2 years
Arousal Index2
2 years
Desaturation Index1
2 years
Desaturation Index2
2 years

Study Arms (2)

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

Medical Air vs OxygenBiological

Medical Air/Oxygen will be given

Arm A: Medical air followed by oxygenArm B: Oxygen followed by medical air

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 2 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

Sponsors & Collaborators

The Hospital for Sick Children
Otherlead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

MeSH Terms

Conditions

Sleep Apnea, CentralPrader-Willi Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsAbnormalities, MultipleCongenital Abnormalities

Study Officials

Reshma Amin, MD
The Hospital for Sick Children
PRINCIPAL INVESTIGATOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: 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).
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Respirologist, Clinician Investigator

Study Record Dates

First Submitted

January 20, 2017

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

Arm A: Medical air followed by oxygen

Arm B: Oxygen followed by medical air

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

Arm A: Medical air followed by oxygen

Arm B: Oxygen followed by medical air

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations