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CompletedNCT01175031Updated Oct 31, 2018Results posted

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

An interventional study of Manipulation of Positive Airway Pressure (PAP) in Sleep Apnea Central, Cheyne-Stokes Respiration and Obstructive Sleep Apnea, sponsored by Philips Respironics. Completed at 3 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Philips Respironics · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Sleep Apnea Central
  • Cheyne-Stokes Respiration
  • Obstructive Sleep Apnea
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • OtherManipulation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During a single night of polysomnography lasting an average of 8 hours

Secondary outcomes

  1. 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.

    Time frame: During a single night of polysomnography lasting an average of 8 hours

  2. 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.

    Time frame: During a single night of polysomnography lasting an average of 8 hours

  3. 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.

    Time frame: During a single night of polysomnography lasting an average of 8 hours

07

Results

Posted May 2, 2016

Participant flow

Participant flow — Overall Study
MilestoneSleep Apnea
Started45
Completed45
Not completed0

Outcome measures

PrimaryNumber 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.

Time frame:
During a single night of polysomnography lasting an average of 8 hours
Reported as:
Mean · events/hour
Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography
events/hourREMstar Auto With A-FlexManually Scored Polysomnography (PSG)
Apnea-hyopnea index16.5 ± 13.518.1 ± 18.6
Apnea index11.4 ± 9.911.5 ± 16.0
Hypopnea index5.1 ± 5.06.6 ± 7.5
Respiratory effort-related arousal (RERA) index2.8 ± 2.06.3 ± 7.4
Statistical analysis
  • REMstar Auto With A-Flex vs Manually Scored Polysomnography (PSG) · signed-rank tests · p = 0.003
SecondaryDevice 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.

Time frame:
During a single night of polysomnography lasting an average of 8 hours
Reported as:
Number · events
Device Detected Apneas as Detected by Philips Respironics (PR) System One
eventsDevice-Detected Apneas
Apnea with obstructed Airway762
Apnea with clear airway335
SecondaryDevice-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.

Time frame:
During a single night of polysomnography lasting an average of 8 hours
Reported as:
Number · events
Device-Detected Obstructed Airway Apnea Agreement
eventsDevice-Detected Obstructive Airway Apneas
Manually Scored Obstructive Apnea367
Manually Scored Central Apnea159
Manually Scored Hypopnea180
Manually Scored RERA56
SecondaryDevice-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.

Time frame:
During a single night of polysomnography lasting an average of 8 hours
Reported as:
Number · events
Device-Detected Clear Airway Apnea Agreement
eventsDevice-Detected Clear Airway Apneas
Manually Scored Obstructive Apnea53
Manually Scored Central Apnea209
Manually Scored Hypopnea49
Manually Scored RERA24

Adverse events

Collected over Adverse events were collected from screening until visit 2, these two visits were up to 7 days apart.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Subjects With Sleep Apnea—0/45 (0%)0/45 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sleep Apnea
Mean53.2 ± 13.9
Sex: Female, Male
Sex: Female, Male(Participants)Sleep Apnea
Female16
Male29
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Sleep Apnea
Caucasian32
African American8
Hispanic/Latino2
Others3
Region of Enrollment
Region of Enrollment(participants)Sleep Apnea
United States45
Body mass index
Body mass index(kg/m^2)Sleep Apnea
Mean53.2 ± 13.9
Diagnostic Apnea-Hypopnea Index (AHI)
Diagnostic Apnea-Hypopnea Index (AHI)(events/hour)Sleep Apnea
Mean39.3 ± 26.0
Diagnosis
Diagnosis(participants)Sleep Apnea
Obstructive Sleep apnea32
Complex Sleep Apnea13
08

Study locations

3 sites
  • National Jewish Health
    Denver, Colorado 80206, United States
  • University of Florida - Shands Sleep Disorders Center
    Gainesville, Florida 32606, United States
  • Sleep Health
    Portage, Michigan 49024, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01175031
Lead sponsor
Philips Respironics
Responsible party
Sponsor
First posted
Aug 4, 2010
Start date
Sep 2010
Primary completion
Jun 2013
Completion
Sep 2013
Results posted
May 2, 2016
Last update
Oct 31, 2018

Study contacts

Richard Berry, MD
principal investigator · University of Florida
Sheila Tsai, MD
principal investigator · National Jewish Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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