Trial Outcomes & Findings for Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography (NCT NCT01175031)

Last Updated: 2018-10-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

During a single night of polysomnography lasting an average of 8 hours

Results posted on

2018-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sleep Apnea n=45 Participants 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.
Age, Continuous	53.2 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	32 participants n=5 Participants
Race/Ethnicity, Customized African American	8 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	2 participants n=5 Participants
Race/Ethnicity, Customized Others	3 participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Body mass index	53.2 kg/m^2 STANDARD_DEVIATION 13.9 • n=5 Participants
Diagnostic Apnea-Hypopnea Index (AHI)	39.3 events/hour STANDARD_DEVIATION 26.0 • n=5 Participants
Diagnosis Obstructive Sleep apnea	32 participants n=5 Participants
Diagnosis Complex Sleep Apnea	13 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	REMstar Auto With A-Flex n=45 Participants 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 and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.	Manually Scored Polysomnography (PSG) n=45 Participants 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 and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.
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	18.1 events/hour Standard Deviation 18.6
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	11.5 events/hour Standard Deviation 16.0
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 5.0	6.6 events/hour Standard Deviation 7.5
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 2.0	6.3 events/hour Standard Deviation 7.4

SECONDARY outcome

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

Population: 1097 Device Detected Apneas were detected.

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.

Outcome measures

Outcome measures
Measure	REMstar Auto With A-Flex n=1097 Device Detected Events 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 and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.	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 measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.
Device Detected Apneas as Detected by Philips Respironics (PR) System One Apnea with obstructed Airway	762 events	—
Device Detected Apneas as Detected by Philips Respironics (PR) System One Apnea with clear airway	335 events	—

SECONDARY outcome

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

Population: 762 Device Detected Apneas were detected.

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.

Outcome measures

Outcome measures
Measure	REMstar Auto With A-Flex n=762 Device Detected Obstructed Airway Apneas 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 and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.	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 measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.
Device-Detected Obstructed Airway Apnea Agreement Manually Scored Hypopnea	180 events	—
Device-Detected Obstructed Airway Apnea Agreement Manually Scored RERA	56 events	—
Device-Detected Obstructed Airway Apnea Agreement Manually Scored Obstructive Apnea	367 events	—
Device-Detected Obstructed Airway Apnea Agreement Manually Scored Central Apnea	159 events	—

SECONDARY outcome

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

Population: 335 Device Detected Clear Airway Apneas were detected.

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.

Outcome measures

Outcome measures
Measure	REMstar Auto With A-Flex n=45 Participants 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 and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.	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 measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG). 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. It will be measure by the REMstar Auto with A-Flex and manually scored PSG.
Device-Detected Clear Airway Apnea Agreement Manually Scored Obstructive Apnea	53 events	—
Device-Detected Clear Airway Apnea Agreement Manually Scored Central Apnea	209 events	—
Device-Detected Clear Airway Apnea Agreement Manually Scored Hypopnea	49 events	—
Device-Detected Clear Airway Apnea Agreement Manually Scored RERA	24 events	—

Adverse Events

Subjects With Sleep Apnea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Quing Yun Li, MD, PhD

Shanghai Jiao Tong University School of Medicine

Phone: 86-21-64314162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60