Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
Healthy Volunteers
NCT06609694

Comparison of a Demand Oxygen Delivery

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-07

10

Participants Needed

1

Research Sites

307 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Comparison of a Demand Oxygen Delivery

Who Can Participate

Age: 5Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 5-17 years with or without Down Syndrome
  • Diagnosis of obstructive sleep apnea with an obstructive apnea hypopnea index between 5 and 40 per hour
  • No clinically significant hypoxia defined as oxygen saturation below 88% for 5 minutes or episodic desaturation to 60%
Not Eligible

You will not qualify if you...

  • Current use of CPAP with documented compliance of more than 4 hours per night on over 70% of nights
  • Oxygen saturation below 90% at rest during wakefulness
  • Chronic use of supplemental oxygen during day or night
  • Inability to participate in a polysomnogram
  • Enrollment in another study that may conflict with this trial or affect results

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

S

Suzie Hicks, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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