Health TrialsbyHealthPanel

Comparison of a Demand Oxygen Delivery

ConditionObstructive Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)Experimental treatment 1 intervention
Group B: Reducing the frequency of obstructive apnea (Main study)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour

Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or \< 5 /hour

Time frame
6 months

Secondary outcomes

1

Value of Oxygen Saturation (SpO2)

The total value of how much oxygen saturation happens while sleeping will be measured at baseline and 6 month visit.

Time frame
6 months
2

Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%

At the baseline and 6 month visit will measure the number of times that SpO2 falls below 90% will sleeping.

Time frame
6 months
3

Pulse Rate during sleep

Mean pulse rate during the total sleep time (beats per min) as well as the maximum pulse rate will be captured during sleep.

Time frame
6 months
4

Frequency of apnea happening during sleep

The total number of apnea events occurring per hour will be measured during sleep

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
Apply now