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

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01175031
• Collaborator: (none)
• Enrollment: 45
• Locations: 3
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 15
• Patients Per Site Per Month: 0.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Central; Cheyne-Stokes Respiration; Obstructive Sleep Apnea	Other: Manipulation of Positive Airway Pressure (PAP)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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); 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.
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); 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Jewish Health	Denver	Colorado	United States	80206
2	University of Florida - Shands Sleep Disorders Center	Gainesville	Florida	United States	32606
3	Sleep Health	Portage	Michigan	United States	49024

Sponsors and Collaborators

• Philips Respironics

Investigators

• Principal Investigator: Richard Berry, MD, University of Florida
• Principal Investigator: Sheila Tsai, MD, National Jewish Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT01175031
• Other Study ID Numbers: ST-1002-PRS1ED-MS
• First Posted: Aug 4, 2010
• Last Update Posted: Oct 31, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cheyne-Stokes Respiration; Sleep Apnea, Central

Study Results

Participant Flow

Arm/Group Title	Sleep Apnea
Arm/Group Description	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.
Period Title: Overall Study
STARTED	45
COMPLETED	45
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sleep Apnea
Arm/Group Description	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 Participants	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.2 (13.9)
Sex: Female, Male (Count of Participants)
Female	16 35.6%
Male	29 64.4%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	32 71.1%
African American	8 17.8%
Hispanic/Latino	2 4.4%
Others	3 6.7%
Region of Enrollment (participants) [Number]
United States	45 100%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	53.2 (13.9)
Diagnostic Apnea-Hypopnea Index (AHI) (events/hour) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [events/hour]	39.3 (26.0)
Diagnosis (participants) [Number]
Obstructive Sleep apnea	32 71.1%
Complex Sleep Apnea	13 28.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REMstar Auto With A-Flex	Manually Scored Polysomnography (PSG)
Arm/Group 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 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.	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.
Measure Participants	45	45
Apnea-hyopnea index	16.5 (13.5)	18.1 (18.6)
Apnea index	11.4 (9.9)	11.5 (16.0)
Hypopnea index	5.1 (5.0)	6.6 (7.5)
Respiratory effort-related arousal (RERA) index	2.8 (2.0)	6.3 (7.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REMstar Auto With A-Flex, Manually Scored Polysomnography (PSG)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	signed-rank tests
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

1097 Device Detected Apneas were detected.

Arm/Group Title	Device-Detected Apneas
Arm/Group Description	Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
Measure Participants	45
Measure Device Detected Events	1097
Apnea with obstructed Airway	762
Apnea with clear airway	335

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

762 Device Detected Apneas were detected.

Arm/Group Title	Device-Detected Obstructive Airway Apneas
Arm/Group Description	Of the device-detected obstructive airway apneas a comparison was done of manually scored verses device detected.
Measure Participants	45
Measure Device Detected Obstructed Airway Apneas	762
Manually Scored Obstructive Apnea	367
Manually Scored Central Apnea	159
Manually Scored Hypopnea	180
Manually Scored RERA	56

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

335 Device Detected Clear Airway Apneas were detected.

Arm/Group Title	Device-Detected Clear Airway Apneas
Arm/Group Description	Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
Measure Participants	45
Measure Device Detected Clear Airway Apneas	335
Manually Scored Obstructive Apnea	53
Manually Scored Central Apnea	209
Manually Scored Hypopnea	49
Manually Scored RERA	24

Adverse Events

Time Frame	Adverse events were collected from screening until visit 2, these two visits were up to 7 days apart.
Arm/Group Title	Subjects With Sleep Apnea
Arm/Group Description	Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory.
All Cause Mortality
	Subjects With Sleep Apnea
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects With Sleep Apnea
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Subjects With Sleep Apnea
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.