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

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Cheyne-Stokes Respiration; Sleep Apnea Central
• Intervention / Treatment: Other: Manipulation of Positive Airway Pressure (PAP)

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Gainesville, Florida, United States, 32606
      • University of Florida - Shands Sleep Disorders Center
  • Michigan
    • Portage, Michigan, United States, 49024
      • Sleep Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REMstar Auto with A-Flex; Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking 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. Events will be measured with REMstar Auto with A-Flex.	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.
Other: Manually Scored Polysomnography (PSG); Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking 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. Events will be Manually Scored Polysomnography (PSG).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography	The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.	During a single night of polysomnography lasting an average of 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Detected Apneas as Detected by Philips Respironics (PR) System One	All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway.	During a single night of polysomnography lasting an average of 8 hours
Device-Detected Obstructed Airway Apnea Agreement	Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs.	During a single night of polysomnography lasting an average of 8 hours
Device-Detected Clear Airway Apnea Agreement	Device Detected Clear Airways events were counted by the device. These events were then compared to manual PSG scoring. The manual PSG scoring determined that these were apnea events. However, the manual scoring allows for more channels to be reviewed and manual scoring was able to classify them into 4 different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored hypopneas and manually scored RERAs.	During a single night of polysomnography lasting an average of 8 hours

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Richard Berry, MD, University of Florida; Principal Investigator: Sheila Tsai, MD, National Jewish Health

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 4, 2010

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Cheyne-Stokes Respiration; Sleep Apnea, Central
• Other Study ID Numbers: ST-1002-PRS1ED-MS