Comparison of a Demand Oxygen Delivery

Conditions

• Obstructive Apnea

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Accepted

Interventions

• Portable oxygen concentrator Inogen G5 model — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jan 9, 2023

Status verified

Jan 2026

Primary completion

Dec 1, 2027

Completion

Dec 1, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

• Suzie Hicks, BS
  513-636-4944
  [email protected]

Locations (1)

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