Comparison of a Demand Oxygen Delivery

Description

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.

Conditions

Obstructive Apnea

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Study Overview

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Study Details

Study overview

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.

Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep

Comparison of a Demand Oxygen Delivery

Condition
Obstructive Apnea
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 5-17 years with or without Down Syndrome (DS).
  • 2. Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
  • 3. Absence of clinically significant hypoxia defined as oxygen saturation \< 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
  • 1. Current CPAP use with documented compliance (\> 4 hrs/ night; \> 70% of nights).
  • 2. Oxygen saturation \< 90% at rest during wakefulness
  • 3. Chronic daytime or nighttime use of supplemental oxygen.
  • 4. Unable to participate in a Polysomnogram (PSG).
  • 5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Ages Eligible for Study

5 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Raouf Amin, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

2026-12-01