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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2025-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea, Central Prader-Willi Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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).

Study Groups

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Arm A: Medical air followed by oxygen

Group Type EXPERIMENTAL

Medical Air vs Oxygen

Intervention Type BIOLOGICAL

Medical Air/Oxygen will be given

Arm B: Oxygen followed by medical air

Group Type EXPERIMENTAL

Medical Air vs Oxygen

Intervention Type BIOLOGICAL

Medical Air/Oxygen will be given

Interventions

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Medical Air vs Oxygen

Medical Air/Oxygen will be given

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No