Recruiting

Demand Oxygen Delivery

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06609694

Conditions

Obstructive Apnea

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Accepted

Interventions

Portable oxygen concentrator Inogen G5 model

Study Details

Brief summary:

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

Study ID

NCT06609694

Start date

Jan 9, 2023

Status verified date

Jan, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

experimental: Reducing the frequency of obstructive apnea (Main study)

The arm of the main study is still under development

Interventions

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.

Primary outcome measure

  • Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Sleep Apnea
  • Down Syndrome
  • Continuous Positive Airway Pressure (CPAP)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-01-07.