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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01175031
First received: July 30, 2010
Last updated: March 29, 2016
Last verified: March 2016
  Purpose
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).

Condition Intervention
Sleep Apnea Central
Cheyne-Stokes Respiration
Obstructive Sleep Apnea
Other: Manipulation of Positive Airway Pressure (PAP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography [ Time Frame: During a single night of polysomnography lasting an average of 8 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Device Detected Apneas as Detected by Philips Respironics (PR) System One [ Time Frame: During a single night of polysomnography lasting an average of 8 hours ] [ Designated as safety issue: No ]
    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.

  • Device-Detected Obstructed Airway Apnea Agreement [ Time Frame: During a single night of polysomnography lasting an average of 8 hours ] [ Designated as safety issue: No ]
    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.

  • Device-Detected Clear Airway Apnea Agreement [ Time Frame: During a single night of polysomnography lasting an average of 8 hours ] [ Designated as safety issue: No ]
    Device Detected Clear Airways were broken down and then reviewed with the manually scored apneas. Of the clear 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.


Enrollment: 45
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175031

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Florida
University of Florida - Shands Sleep Disorders Center
Gainesville, Florida, United States, 32606
United States, Michigan
Sleep Health
Portage, Michigan, United States, 49024
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Richard Berry, MD University of Florida
Principal Investigator: Sheila Tsai, MD National Jewish Health
  More Information

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01175031     History of Changes
Other Study ID Numbers: ST-1002-PRS1ED-MS 
Study First Received: July 30, 2010
Results First Received: October 29, 2015
Last Updated: March 29, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Cheyne-Stokes Respiration
Sleep Apnea Syndromes
Sleep Apnea, Central
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders

ClinicalTrials.gov processed this record on May 26, 2016