Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy
 of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended
 clinical polysomnography (PSG) in identifying breathing events in participants previously
 diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes
 respiration (CSR), or obstructive sleep apnea (OSA).
Study Objectives: To compare a positive airway pressure (PAP) device's detection of
 respiratory events and airway status during device detected apneas with events scored on
 simultaneous polysomnography (PSG).

 Design: Prospective PSGs of patients with sleep apnea using a new-generation PAP device.

 Settings: Four clinical and academic sleep centers.

 Patients: Forty-five patients with obstructive sleep apnea (OSA) and complex sleep apnea
 (Comp SA) performed a PSG on PAP levels adjusted to induce respiratory events.

 Interventions: None.
Inclusion Criteria:

 -  Males and females, ages 21-80.

 -  Able and willing to provide written informed consent.

 -  Diagnosis of complex sleep apnea (CompSAS) or Obstructive Sleep Apnea (OSA) within one
 year of study participation.

 -  For participants with CompSAS: (a) Diagnostic PSG with an Apnea-Hyopnea Index (AHI)
 greater than or equal to 10 events/hour and central apnea index (CAI) greater than or
 equal to 5 events/hour of sleep or (b) PAP titration with a CAI greater than or equal
 to 5 events/hour of sleep.

 -  For participants with OSA, a diagnostic PSG with an AHI greater than or equal to 15
 events/hour of sleep.

 -  Must have had a CPAP titration such that the necessary PAP level to treat the sleep
 disordered breathing is known.

 -  Agreement to undergo a full-night, in-laboratory PSG on CPAP device.

 Exclusion Criteria:

 -  Participation in an interventional research study within 30 days of study
 participation.

 -  Pre-menopausal females known to be pregnant or who are sexually active and not using a
 reliable method of birth control.

 -  Surgery of the upper airway, nose, sinus, or middle ear within the last 90 days.

 -  Surgery at any time for the treatment of OSA such as uvulopalatopharyngoplasty (UPPP).

 -  Major medical or psychiatric condition that would interfere with the demands of the
 study, adherence to positive airway pressure, or the ability to complete the study.

 -  Chronic respiratory failure or insufficiency with suspected or known neuromuscular
 disease, moderate or severe Chronic Obstructive Pulmonary Disease (COPD) or other
 pulmonary disorders, or any condition with an elevation of arterial carbon dioxide
 levels (> 45 mmHg) while awake.

 -  Currently prescribed oxygen therapy.

 -  Ventilatory induced barotrauma within 6 months of study participation.

 -  Untreated insomnia.

 -  Other major medical condition that, in the judgment of the investigator, precludes
 participation in this study.