Comparison of a Demand Oxygen Delivery (DOSA)

January 5, 2026 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cincinnati Children's Hospital received NIH funding to conduct a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. Oxygen may be delivered through continuous flow for the duration of the respiratory cycle or pulse flow during inspiration only. Pulse flow oxygen concentrators have been used clinically in adults. However, there is limited experience with this technology in children. The advantages of pulse flow oxygen concentrator are its portability and its ability in providing compliance data.

This is a pilot research study to compare 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. The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea, neurocognitive and cardiac outcomes. A separate Institutional Review Board (IRB) protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Sub-Investigator:
          • Narong Simakajornboon, PhD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion 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.

Exclusion Criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)
The aim of this pilot study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow.
Device: Portable oxygen concentrator Inogen G5 model
The concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 /hour.
Experimental: Reducing the frequency of obstructive apnea (Main study)
The arm of the main study is still under development
Device: Portable oxygen concentrator Inogen G5 model
The concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 /hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour
Time Frame: 6 months
Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or < 5 /hour
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of Oxygen Saturation (SpO2)
Time Frame: 6 months
The total value of how much oxygen saturation happens while sleeping will be measured at baseline and 6 month visit.
6 months
Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%
Time Frame: 6 months
At the baseline and 6 month visit will measure the number of times that SpO2 falls below 90% will sleeping.
6 months
Pulse Rate during sleep
Time Frame: 6 months
Mean pulse rate during the total sleep time (beats per min) as well as the maximum pulse rate will be captured during sleep.
6 months
Frequency of apnea happening during sleep
Time Frame: 6 months
The total number of apnea events occurring per hour will be measured during sleep
6 months
Total hours of Sleep Time
Time Frame: 6 months
Total sleep time will be confirmed by an electroencephalogram (h)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Raouf Amin, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0821
  • R61HL165366 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The primary goal of this study is to assess feasibility of using pulse oxygen flow in children with Down syndrome and obstructive sleep apnea population. Preliminary data on the response rates from the two concentrators will be obtained and a confidence interval for the difference in response rate will be obtained. Data that is obtained from the devices will be shared with Inogen. Data will be deidentified prior to sending.

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

Pending

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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