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Comparison of a Demand Oxygen Delivery

Children's Hospital Medical Center, Cincinnati · with National Heart, Lung, and Blood Institute (NHLBI) · NCT06609694

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–17 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
10
US sites recruiting
1
Study start
January 9, 2023
Record last updated
January 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Portable oxygen concentrator Inogen G5 model

Conditions: Obstructive Apnea

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age 5-17 years with or without Down Syndrome (DS).
  • 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).
  • 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.

Exclusion Criteria

  • Current CPAP use with documented compliance (> 4 hrs/ night; > 70% of nights).
  • Oxygen saturation \< 90% at rest during wakefulness
  • Chronic daytime or nighttime use of supplemental oxygen.
  • Unable to participate in a Polysomnogram (PSG).
  • Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Recruiting US locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Suzie Hicks, BS · 5136364944 · suzie.hicks@cchmc.org

Study contacts (from the official record)

  • Suzie Hicks, BS · 513-636-4944 · suzie.hicks@cchmc.org
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Comparison of a Demand Oxygen Delivery (NCT06609694) | Bored Studies