Back to resultsComparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Primary Purpose
Sleep Apnea Central, Cheyne-Stokes Respiration, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manipulation of Positive Airway Pressure (PAP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea Central
Eligibility 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.
Sites / Locations
- National Jewish Health
- University of Florida - Shands Sleep Disorders Center
- Sleep Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
REMstar Auto with A-Flex
Manually Scored Polysomnography (PSG)
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01175031
Brief Title
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Official Title
Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Central, Cheyne-Stokes Respiration, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REMstar Auto with A-Flex
Arm Type
Experimental
Arm Description
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.
Arm Title
Manually Scored Polysomnography (PSG)
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Manipulation of Positive Airway Pressure (PAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography
Description
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.
Time Frame
During a single night of polysomnography lasting an average of 8 hours
Secondary Outcome Measure Information:
Title
Device Detected Apneas as Detected by Philips Respironics (PR) System One
Description
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.
Time Frame
During a single night of polysomnography lasting an average of 8 hours
Title
Device-Detected Obstructed Airway Apnea Agreement
Description
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.
Time Frame
During a single night of polysomnography lasting an average of 8 hours
Title
Device-Detected Clear Airway Apnea Agreement
Description
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.
Time Frame
During a single night of polysomnography lasting an average of 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Berry, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheila Tsai, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Florida - Shands Sleep Disorders Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Sleep Health
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
12. IPD Sharing Statement
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Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
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