Cheyne-Stokes Respiration, Obstructive Sleep Apnea, Sleep Apnea Central
Conditions
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.
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.
Sponsors
Philips Respironics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | During a single night of polysomnography lasting an average of 8 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Device Detected Apneas as Detected by Philips Respironics (PR) System One | During a single night of polysomnography lasting an average of 8 hours | 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 | During a single night of polysomnography lasting an average of 8 hours | 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 | During a single night of polysomnography lasting an average of 8 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Apnea Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Sleep Apnea |
|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 13.9 |
| Body mass index | 53.2 kg/m^2 STANDARD_DEVIATION 13.9 |
| Diagnosis Complex Sleep Apnea | 13 participants |
| Diagnosis Obstructive Sleep apnea | 32 participants |
| Diagnostic Apnea-Hypopnea Index (AHI) | 39.3 events/hour STANDARD_DEVIATION 26 |
| Race/Ethnicity, Customized African American | 8 participants |
| Race/Ethnicity, Customized Caucasian | 32 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 2 participants |
| Race/Ethnicity, Customized Others | 3 participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REMstar Auto With A-Flex | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Apnea-hyopnea index | 16.5 events/hour | Standard Deviation 13.5 |
| REMstar Auto With A-Flex | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Apnea index | 11.4 events/hour | Standard Deviation 9.9 |
| REMstar Auto With A-Flex | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Hypopnea index | 5.1 events/hour | Standard Deviation 5 |
| REMstar Auto With A-Flex | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Respiratory effort-related arousal (RERA) index | 2.8 events/hour | Standard Deviation 2 |
| Manually Scored Polysomnography (PSG) | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Respiratory effort-related arousal (RERA) index | 6.3 events/hour | Standard Deviation 7.4 |
| Manually Scored Polysomnography (PSG) | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Apnea-hyopnea index | 18.1 events/hour | Standard Deviation 18.6 |
| Manually Scored Polysomnography (PSG) | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Hypopnea index | 6.6 events/hour | Standard Deviation 7.5 |
| Manually Scored Polysomnography (PSG) | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | Apnea index | 11.5 events/hour | Standard Deviation 16 |
p-value: 0.003signed-rank tests
Secondary
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
Population: 1097 Device Detected Apneas were detected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REMstar Auto With A-Flex | Device Detected Apneas as Detected by Philips Respironics (PR) System One | Apnea with obstructed Airway | 762 events |
| REMstar Auto With A-Flex | Device Detected Apneas as Detected by Philips Respironics (PR) System One | Apnea with clear airway | 335 events |
Secondary
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
Population: 335 Device Detected Clear Airway Apneas were detected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REMstar Auto With A-Flex | Device-Detected Clear Airway Apnea Agreement | Manually Scored Obstructive Apnea | 53 events |
| REMstar Auto With A-Flex | Device-Detected Clear Airway Apnea Agreement | Manually Scored Central Apnea | 209 events |
| REMstar Auto With A-Flex | Device-Detected Clear Airway Apnea Agreement | Manually Scored Hypopnea | 49 events |
| REMstar Auto With A-Flex | Device-Detected Clear Airway Apnea Agreement | Manually Scored RERA | 24 events |
Secondary
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
Population: 762 Device Detected Apneas were detected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REMstar Auto With A-Flex | Device-Detected Obstructed Airway Apnea Agreement | Manually Scored Obstructive Apnea | 367 events |
| REMstar Auto With A-Flex | Device-Detected Obstructed Airway Apnea Agreement | Manually Scored Central Apnea | 159 events |
| REMstar Auto With A-Flex | Device-Detected Obstructed Airway Apnea Agreement | Manually Scored Hypopnea | 180 events |
| REMstar Auto With A-Flex | Device-Detected Obstructed Airway Apnea Agreement | Manually Scored RERA | 56 events |