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Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea

NCT01846988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-04-23

Study results available
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Summary

The purpose of this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The difference is that APAP adjusts the pressure throughout the night with changes in resistance during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP is currently widely used to treat adults with OSA, however, this device has not yet been extensively studied in children.

There are two parts to this research study. Subjects will begin using APAP at the time of enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP device over the 4-8 weeks with the pressure determined by a CPAP titration study. The titration study is a second overnight sleep study that is routinely ordered when a child with sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used.

In the second part of this study The investigators will compare the effects of APAP with CPAP to see what is reported as more comfortable and is used during more hours of sleep. This part of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks each.

Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP until the results of the titration study are available. In this research, patients could be allowed to immediately start treatment with APAP. If APAP is found to be as safe and effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.

Conditions

Interventions

DEVICE

crossover treatment (REMstar Auto A-Flex)

All subjects will use same device with 4 week crossover of settings of APAP and CPAP

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Narong Simakajornboon, MD · Children's Hospital Medical Center, Cincinnati

  • Neepa Gurbani, DO · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2018-12-01
Completion
2019-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846988 on ClinicalTrials.gov