NCT00836758

Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.

Detailed description

Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with manually scored events on PSG. The PAP device was modified to produce a square wave voltage output identifying when apneas, hypopneas, and snoring events were detected. Recording this event signal on the PSG performed with the patient using the PAP device allowed an event-by-event comparison between manually scored PSG events and AED events. In addition, the AHI, AI, and HI derived from the manually scored PSG were compared with the respective measures reported by the PAP device used during the PSG. Study Objectives: Compare automatic event detection (AED) of respiratory events using a positive airway pressure (PAP) device with manual scoring of polysomnography (PSG) during PAP treatment of obstructive sleep apnea (OSA). Design: Prospective PSGs of patients using a PAP device. Setting: Six academic and private sleep disorders centers. Interventions: A signal generated by the PAP device identifying the AED of respiratory events based on airflow was recorded during PSG.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Analysis with AED and manual PSG scoring	The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-02-04
• Last updated: 2019-01-16
• Results posted: 2019-01-16

Locations

1 site across 1 country: United States