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Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography

This study is currently recruiting participants.
Verified July 2010 by Philips Respironics
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01175031
First received: July 30, 2010
Last updated: November 30, 2012
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the CPAP (continuous positive airway pressure) 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
Complex Sleep Apnea
Cheyne-Stokes Respiration
Obstructive Sleep Apnea
 Device: REMstar Auto with A-Flex

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel 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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Evidence of diagnostic agreement between breathing events identified by the CPAP device compared to a simultaneous polysomnography confirmed by using accepted sleep disordered breathing severity groupings. [ Time Frame: During a single night of polysomnography lasting an average of 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of a significant correlation between breathing events identified by the CPAP device compared to a simultaneous polysomnography confirmed by using accepted sleep disordered breathing severity groupings. [ Time Frame: During a single night of polysomnography lasting an average of 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CompSAS
Complex Sleep Apnea
 Device: REMstar Auto with A-Flex
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.
Experimental: CSR
Complex Sleep Apnea with Cheyne-Stokes Respiration
 Device: REMstar Auto with A-Flex
Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, decreased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.
Experimental: OSA
Obstructive Sleep Apnea
 Device: REMstar Auto with A-Flex
Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, decreased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.

  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 CompSAS or OSA within one year of study participation.
  • For participants with CompSAS: (a) Diagnostic PSG with an AHI greater than or equal to 10 events/hour and 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175031

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Kelly Goelz     303-398-1597     goelzk@njhealth.org    
Principal Investigator: Sheila Tsai, MD            
United States, Florida
University of Florida - Shands Sleep Disorders Center Recruiting
Gainesville, Florida, United States, 32606
Contact: Susan Purdy     352-265-5240     Susan.Purdy@medicine.ufl.edu    
Principal Investigator: Richard Berry, MD            
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Richard Berry, MD University of Florida
Principal Investigator: Sheila Tsai, MD National Jewish Health
  More Information

No publications provided

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
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013