Sleep Apnea Clinical Trial
Official title:
Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography
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.
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.
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