SV3-ST: Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

• Sponsor: Philips Respironics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01241604
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disordered Breathing	Device: BiPAP S/T; Device: BiPAP Auto SV3	N/A

Detailed Description

Primary Hypothesis and end-point:

The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:

• Apnea-Hypopnea Index (AHI)

Secondary Hypothesis and end-points:

The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:

• Sleep Variables

• REM, NREM and Total Sleep Time (TST) Indices

• Apnea Hypopnea Index (AHI)

• Center Apnea Index(CAI)

• Obstructive Apnea Index (OAI)

• Mixed Apnea Index (MAI)

• Hypopnea Index (HI)

• Sleep Onset Latency (SOL)

• REM Onset Latency (ROL)

• Wake After Sleep Onset (WASO)

• Total Sleep Time (TST)

• Sleep Efficiency (SE %)

• Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)

• Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)

• Arousal Index [total, AH-related, PLM-related, 'spontaneous']

• Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)

• AHI (REM, NREM and TST) using modified hypopnea rule.

• AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Respironics BiPAP S/T Control Arm using Respironics BiPAP S/T	Device: BiPAP S/T; Mechanical Non-invasive Ventilation; Other Names: Respironics BiPAP S/T
Active Comparator: Respironics BiPAP Auto SV3 Treatment arm using Respironics BiPAP Auto SV3	Device: BiPAP Auto SV3; Auto Servo Ventilation Device; Other Names: Respironics BiPAP auto SV Advanced

Outcome Measures

Primary Outcome Measures

1. Apnea Hypopnea Index [2 nights]

   The number of apneas and hypopneas per hour of sleep.

Secondary Outcome Measures

1. Apnea Hypopnea Index- REM [2 nights]

   The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).

2. Central Apnea Index [2 nights]

   The central apnea index is the number of central apneas divided by the number of hours of sleep.

3. Obstructive Apnea Index [2 nights]

   The obstructive apnea index is the number of obstructive apneas per hour of sleep.

4. Mixed Apnea Index [2 nights]

   The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.

5. Hypopnea Index [2 nights]

   The hypopnea index is number hypopneas per hour.

6. Sleep Onset Latency [2 nights]

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

7. REM Onset Latency [2 nights]

   REM Onset Latency is the time it takes to fall into REM sleep.

8. Wake After Sleep Onset [2 nights]

   Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.

9. Total Sleep Time [2 nights]

   Total Sleep time is total amount of time a participant is asleep from lights off to lights on.

10. Sleep Efficiency [2 nights]

    Sleep Efficiency is the percentage of time spent asleep while in bed.

11. Periodic Limb Movement Index [2 nights]

    The periodic limb movement is the number of periodic limb movements per hour of sleep.

12. Arousal Index [2 nights]

    The arousal index is the number of arousals or awakenings per hour of sleep.

13. Stages N1,N2,N3 and REM (R) Sleep (% TST) [2 nights]

    The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.

14. Stages N1,N2,N3 and REM (R) Sleep (in Minutes) [2 nights]

    The average amount of time spent N1, N2, N3 and REM in minutes per night.

15. Nocturnal Oxygenation Index [2 nights]

    Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.

16. Apnea Hypopnea Index Using Modified Hypopnea Rule. [2 nights]

    The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.

17. Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits. [2 nights]

    The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.

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.

• Currently using BiPAP S/T (At least 4 weeks on therapy).

• Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.

Exclusion Criteria:

• Participants, who are acutely ill, medically complicated or who are medically unstable.

• Participants in whom PAP therapy is otherwise medically contraindicated.

• Participants who are unwilling to wear PAP.

• Participants who are currently prescribed oxygen therapy.

• 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)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index > 15).

• Participants who are unwilling to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Med One Medical Sleep Laboratory	Salt Lake City	Utah	United States	84121

Sponsors and Collaborators

• Philips Respironics

Investigators

• Principal Investigator: Brydon Grant, MD, Medical Director of Med One Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT01241604
• Other Study ID Numbers: MR-0830-ASV3-ST-SS
• First Posted: Nov 16, 2010
• Last Update Posted: Apr 9, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Sleep Apnea Syndromes

Study Results

Participant Flow

Recruitment Details	Patients were recruited from one site to evaluate software enhancements. The study enrolled patients in the spring of 2009.

Arm/Group Title	Screening Population	Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3	Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T
Arm/Group Description	All participants that signed consent are considered for the screening population.	Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device	Auto Servo Ventilation Device and then Mechanical Non-invasive Ventilation
Period Title: Screening Period
STARTED	11	0	0
COMPLETED	8	0	0
NOT COMPLETED	3	0	0
Period Title: Screening Period
STARTED	0	5	3
COMPLETED	0	5	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants that were consented.
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 75%
>=65 years	2 25%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.4 (9.2)
Sex: Female, Male (Count of Participants)
Female	3 37.5%
Male	5 62.5%
Region of Enrollment (participants) [Number]
United States	8 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.8 (3.8)

Outcome Measures

1. Primary Outcome

Title	Apnea Hypopnea Index
Description	The number of apneas and hypopneas per hour of sleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [events per hour]	19.24 (16.72)	15.85 (17.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Respironics BiPAP S/T, Respironics BiPAP Auto SV3
	Comments
	Type of Statistical Test	Equivalence
	Comments	Equivalent non-parametric tests
Statistical Test of Hypothesis	p-Value	.753
	Comments
	Method	Wilcoxon signed ranks test
	Comments

2. Secondary Outcome

Title	Apnea Hypopnea Index- REM
Description	The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [events per hour]	10.16 (5.14)	4.21 (4.49)

3. Secondary Outcome

Title	Central Apnea Index
Description	The central apnea index is the number of central apneas divided by the number of hours of sleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [events per hour]	0.14 (0.25)	0.11 (0.14)

4. Secondary Outcome

Title	Obstructive Apnea Index
Description	The obstructive apnea index is the number of obstructive apneas per hour of sleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [events per hour]	0 (0)	0 (0)

5. Secondary Outcome

Title	Mixed Apnea Index
Description	The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [events per hour]	0 (0)	0 (0)

6. Secondary Outcome

Title	Hypopnea Index
Description	The hypopnea index is number hypopneas per hour.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [events per hour]	19.1 (16.54)	15.74 (17.23)

7. Secondary Outcome

Title	Sleep Onset Latency
Description	Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [minutes]	43.25 (41.98)	64.58 (81.64)

8. Secondary Outcome

Title	REM Onset Latency
Description	REM Onset Latency is the time it takes to fall into REM sleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

This analysis was not done because this is not a standard measurement.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	0	0

9. Secondary Outcome

Title	Wake After Sleep Onset
Description	Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [minutes]	72.58 (63.25)	67.67 (39.86)

10. Secondary Outcome

Title	Total Sleep Time
Description	Total Sleep time is total amount of time a participant is asleep from lights off to lights on.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [minutes]	331.83 (66.7)	352.67 (63.5)

11. Secondary Outcome

Title	Sleep Efficiency
Description	Sleep Efficiency is the percentage of time spent asleep while in bed.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [percentage of time asleep]	74.78 (12.36)	73.42 (16.96)

12. Secondary Outcome

Title	Periodic Limb Movement Index
Description	The periodic limb movement is the number of periodic limb movements per hour of sleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [movements per hour]	7.32 (10.4)	4 (5.90)

13. Secondary Outcome

Title	Arousal Index
Description	The arousal index is the number of arousals or awakenings per hour of sleep.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [arousals per hour]	27.33 (14.3)	23.76 (15.11)

14. Secondary Outcome

Title	Stages N1,N2,N3 and REM (R) Sleep (% TST)
Description	The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Stage N1	2.16 (2.95)	1.37 (0.82)
Stage N2	82.48 (15.54)	83.44 (9.01)
Stage N3	4.1 (8.14)	4.27 (8.06)
REM	11.26 (8.13)	10.92 (4.8)

15. Secondary Outcome

Title	Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
Description	The average amount of time spent N1, N2, N3 and REM in minutes per night.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Stage N1	7.17 (10.46)	4.83 (3.33)
Stage N2	271.33 (70.03)	294.92 (67.18)
Stage N3	15.25 (28.02)	17.25 (23.01)
REM	37.92 (32.74)	37.67 (17.44)

16. Secondary Outcome

Title	Nocturnal Oxygenation Index
Description	Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	6	6
Mean (Standard Deviation) [oxygen saturation index]	24 (24.9)	19.93 (19.97)

17. Secondary Outcome

Title	Apnea Hypopnea Index Using Modified Hypopnea Rule.
Description	The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

The Apnea Hyopnea Index(AHI) was analyzed and results were provided. The AHI using the modified hypopnea rule was not conducted. This is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	0	0

18. Secondary Outcome

Title	Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
Description	The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.
Time Frame	2 nights

Outcome Measure Data

Analysis Population Description

The Apnea Hypopnea Index (AHI) was analyzed and results were provided. However the epochs were not separated out as this is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.

Arm/Group Title	Respironics BiPAP S/T	Respironics BiPAP Auto SV3
Arm/Group Description	Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Measure Participants	0	0

Adverse Events

Time Frame	2 nights
Arm/Group Title	Screening Period		Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3		Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T
Arm/Group Description	All participants that were consented into the study.		Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device		Auto Servo Ventilation Device first and then Mechanical Non-invasive Ventilation
All Cause Mortality
	Screening Period		Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3		Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Screening Period		Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3		Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/5 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Screening Period		Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3		Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/5 (0%)		0/3 (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.