Shands and UF Sleep Disorder Center
Gainesville, Florida, 32606, United States
NCT Number: NCT00836758
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.
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Notify Me21 year–75 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32606, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: one night
Apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. The Apnea index (AI) is the average number of apneas that occur per hour of sleep. The Hypopnea index (HI) is the average number of hypopneas that occur per hour of sleep.
The PSGs were manually scored to determine the apnea-hypopnea index. This value was then compared to the PAP device which utilized the AED algorithm to determine the apnea-hypopnea index.
Time frame: one night
Methodological comparisons utilizing ICC for detection of AHI, apnea index (AI) and hypopnea index (HI) were caculated between the values obtained by PSG and the REMstar Auto with A-Flex device.
Philips Respironics
Industry
Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography
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