Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01626989
• Collaborator: (none)
• Enrollment: 44
• Locations: 3
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 14.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disordered Breathing; Sleep Apnea, Central	Device: BiPAP auto Advanced; Device: BiPAP auto SV4	N/A

Detailed Description

The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:

• Apnea-Hypopnea Index (AHI)

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders.
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BiPAP auto SV Advanced BiPAP auto SV Advanced	Device: BiPAP auto Advanced; Auto Servo Ventilation Device; Other Names: BiPAP Auto SV
Experimental: BiPAP auto SV 4 Auto Servo Ventilation Device	Device: BiPAP auto SV4; Auto Servo Ventilation Device; Other Names: BiPAP Auto SV

Outcome Measures

Primary Outcome Measures

1. Apnea-Hypopnea Index (AHI) [Baseline, and 2 nights (1 night for each intervention)]

   Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

Secondary Outcome Measures

1. Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices [Baseline, and 2 nights (1 night for each intervention)]

   REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode

2. Central Apnea Index(CAI) [Baseline, and 2 nights (1 night for each intervention)]

   Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.

3. Obstructive Apnea Index (OAI) [Baseline, and 2 nights (1 night for each intervention)]

   Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.

4. Mixed Apnea Index (MAI) [Baseline, and 2 nights (1 night for each intervention)]

   Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.

5. Sleep Onset Latency (SOL) [Baseline, and 2 nights (1 night for each intervention)]

   Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.

6. REM Onset Latency (ROL) [Baseline, and 2 nights (1 night for each intervention)]

   REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.

7. Wake After Sleep Onset (WASO) [Baseline, and 2 nights (1 night for each intervention)]

   Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.

8. Total Sleep Time (TST) [Baseline, and 2 nights (1 night for each intervention)]

   Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode

9. Sleep Efficiency (SE %) [Baseline, and 2 nights (1 night for each intervention)]

   Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.

10. Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep [Baseline, and 2 nights (1 night for each intervention)]

    Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from "lights out," or bedtime, to the onset of sleep.

11. Arousal Index [Baseline, and 2 nights (1 night for each intervention)]

    Arousal Index is the number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep.

12. Nocturnal Oxygenation [Baseline, and 2 nights (1 night for each intervention)]

    Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.

13. Hypopnea Index (HI) [Baseline, and 2 nights (1 night for each intervention)]

    Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 21-80

• Ability to provide consent

• Documentation of medical stability by investigator

• Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.

OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.

• Agreement to undergo a full-night, in-lab research CPAP Titration

• Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices

Exclusion Criteria:

• 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. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.

• Systolic blood pressure < 80 mm Hg at Baseline Visit.

• Participants in whom PAP therapy is otherwise medically contraindicated.

• Participants who are unwilling to wear CPAP

• Currently prescribed oxygen therapy (as needed, nocturnal, or continuous

• Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).

• Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.

• Participants with untreated, non-obstructive Sleep Apnea (OSA)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Center for Sleep Medicine	Little Rock	Arkansas	United States	72205
2	Sleep Health	Portage	Michigan	United States	49024
3	Sleepcare Diagnostics	Mason	Ohio	United States	45040

Sponsors and Collaborators

• Philips Respironics

Investigators

• Principal Investigator: Shahrokh Javaheri, MD, Sleepcare Diagnostics
• Principal Investigator: Paul Wylie, MD, Arkansas Center for Sleep Medicine
• Principal Investigator: Mark Goetting, MD, Sleep Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT01626989
• Other Study ID Numbers: ST-1007-ASV4-MS
• First Posted: Jun 25, 2012
• Last Update Posted: Apr 25, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Central; Sleep Wake Disorders; Parasomnias

Study Results

Participant Flow

Arm/Group Title	Screening Population	BiPAP Auto SV Advanced First, Then BiPAP Auto SV 4	BiPAP Auto SV 4 First, Then BiPAP Auto SV Advanced
Arm/Group Description	All patients that signed consent are considered for the screening population.	Participants received the Philips BiPAP Auto SV Advanced for one night, then received the BiPAP Auto SV 4 for one night.	Participants received the Philips BiPAP Auto SV 4 for one night, then received the BiPAP Auto SV Advanced for one night
Period Title: Screening Period
STARTED	44	0	0
COMPLETED	27	0	0
NOT COMPLETED	17	0	0
Period Title: Screening Period
STARTED	0	15	12
COMPLETED	0	15	12
NOT COMPLETED	0	0	0
Period Title: Screening Period
STARTED	0	15	12
COMPLETED	0	15	12
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants that signed consent.
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	27 61.4%
>=65 years	17 38.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.71 (13.4)
Sex: Female, Male (Count of Participants)
Female	9 20.5%
Male	35 79.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 9.1%
White	39 88.6%
More than one race	0 0%
Unknown or Not Reported	1 2.3%
Region of Enrollment (participants) [Number]
United States	44 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.3 (6.6)

Outcome Measures

1. Primary Outcome

Title	Apnea-Hypopnea Index (AHI)
Description	Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [events per hour]	38 (31)	13 (17)	12 (18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BiPAP Auto SV Advanced, BiPAP Auto SV 4
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Friedman Test comparing all 3 nights
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	nonparametric Wilcoxon Signed Rank test
	Comments

2. Secondary Outcome

Title	Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices
Description	REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Stage 1	22 (14)	18 (10)	17 (10)
Stage 2	61 (14)	65 (13)	65 (12)
Stage 3	5 (8)	4 (6)	5 (6)
REM	11 (9)	13 (9)	14 (11)

3. Secondary Outcome

Title	Central Apnea Index(CAI)
Description	Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis. 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [events per hour]	12 (15)	1 (2)	1 (3)

4. Secondary Outcome

Title	Obstructive Apnea Index (OAI)
Description	Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [events per hour]	14 (10)	1 (2)	2 (4)

5. Secondary Outcome

Title	Mixed Apnea Index (MAI)
Description	Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [events per hour]	4 (7)	0.3 (0.6)	0.6 (2)

6. Secondary Outcome

Title	Sleep Onset Latency (SOL)
Description	Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [minutes]	16.6 (16.3)	19.3 (10.1)	24.3 (20)

7. Secondary Outcome

Title	REM Onset Latency (ROL)
Description	REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

REM onset latency is not a standard set of sleep scores analyzed. This is not apart of the analysis, this is in the protocol by error. However the protocol was not amended.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	0	0	0

8. Secondary Outcome

Title	Wake After Sleep Onset (WASO)
Description	Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [minutes]	59.1 (48)	64.1 (57.6)	54.2 (29.3)

9. Secondary Outcome

Title	Total Sleep Time (TST)
Description	Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [minutes]	354.0 (74.3)	352.4 (69.2)	368.1 (64.6)

10. Secondary Outcome

Title	Sleep Efficiency (SE %)
Description	Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [percent of time asleep]	82 (13)	81 (12)	82 (8)

11. Secondary Outcome

Title	Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep
Description	Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from "lights out," or bedtime, to the onset of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

Data was not analyzed as number of minutes, as minutes is not a meaningful measurement. It is best measured respective to % TST in outcome measure 2. This was included in the protocol in error and the protocol was not amended.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	0	0	0

12. Secondary Outcome

Title	Arousal Index
Description	Arousal Index is the number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [events per hour]	22 (12)	16 (7)	16 (8)

13. Secondary Outcome

Title	Nocturnal Oxygenation
Description	Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [percent oxygen saturation]	82 (7)	86 (4)	84 (5)

14. Secondary Outcome

Title	Hypopnea Index (HI)
Description	Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.
Time Frame	Baseline, and 2 nights (1 night for each intervention)

Outcome Measure Data

Analysis Population Description

8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arm/Group Title	Continous Positive Airway Pressure Titriation	BiPAP Auto SV Advanced	BiPAP Auto SV 4
Arm/Group Description	Baseline PSG to qualify for randomization.	BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Measure Participants	19	19	19
Mean (Standard Deviation) [events per hour]	9 (9)	11 (15)	8 (11)

Adverse Events

Time Frame	3 weeks
Arm/Group Title	All Participants		BiPAP Auto SV Advanced		BiPAP Auto SV 4
Arm/Group Description	All Study participants that were consented to the study.		All participants that received the Philips BiPAP Auto SV Advanced.		All participants that received the Philips BiPAP Auto SV 4.
All Cause Mortality
	All Participants		BiPAP Auto SV Advanced		BiPAP Auto SV 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/27 (0%)		0/27 (0%)
Serious Adverse Events
	All Participants		BiPAP Auto SV Advanced		BiPAP Auto SV 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/27 (0%)		0/27 (0%)
Cardiac disorders
Stents	1/44 (2.3%)	1	0/27 (0%)	0	0/27 (0%)	0
Other (Not Including Serious) Adverse Events
	All Participants		BiPAP Auto SV Advanced		BiPAP Auto SV 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/27 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.