NCT01175031

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

Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Sleep Apnea Central
• Cheyne-Stokes Respiration
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
OTHER	Manipulation of Positive Airway Pressure (PAP)	Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-06-01
• Completion: 2013-09-01
• First posted: 2010-08-04
• Last updated: 2018-10-31
• Results posted: 2016-05-02

Locations

3 sites across 1 country: United States