Servo-Ventilation In-lab PSG Evaluation

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02808338
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 4
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents instability and collapse. With a stable and patent airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing.

Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. The main features of the Auto SV mode include:

• Normalization of ventilation by automatically adjusting Inspiratory Positive Airway Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased to help stabilize the ventilation.

• Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing.

• Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive events.

Several manufacturers produce these types of devices. The algorithms used to determine the IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes	Device: Philips BiPAP AutoSV Advanced System One; Device: Modified Philips BiPAP ASV; Device: ResMed S7 VPAP Adapt; Device: ResMed S9 VPAP Adapt	N/A

Detailed Description

This study is to better understand the performance and features of the BiPAP autoSV Advanced System One. Philips Respironics will evaluate the PolySomnoGraphy (PSG) and Encore data from each night. The aim of the study is to characterize the acute outcomes of treatment provided by the device and evaluate any modifications made to the Philips Respironics device's algorithm

The participants for this study will be experienced in having used servo ventilation therapy at their home because it is only such patients who are already using servo ventilation as part of routine clinical care that are eligible for participation.

Participants will receive four (4) randomized PSG's during which they will receive treatment from the following devices in a randomized manner:

• FDA released Philips BiPAP AutoSV Advanced System One

• A Modified Philips BiPAP ASV

• FDA released ResMed S7 VPAP Adapt

• FDA released ResMed S9 VPAP Adapt

The participants sought for this effort will be previously prescribed a servo-ventilation device as part of routine clinical care.

Baseline with PSG

• Informed Consent

• Inclusion/Exclusion Criteria Review

• Demographics

• Anthropometric Measurements

• PAP Prescription information (if available; from Device or from Medical records). This is the pressure settings of the device that was prescribed by the patient's clinical sleep medicine provider.

• Medical History and physical examination

• Sleep History- Including that past 30 day detailed report

• Diagnostic PSG history (copies of sleep studies that were performed as part of routine clinical care in the past that qualified the patient for the servo-ventilation device)

• Current Medications

• Vital Signs (at beginning of PSG night)

• Research Trial PSG- Randomized to a device Procedures for Each PSG after Baseline

• Current Medications

• Vital Signs (at beginning of PSG night)

• Research Trial PSG- Randomized to one of the four devices (4 research PSGs will be performed for each subject).

30 day Take Home with Modified Philips BiPAP ASV device

After the last PSG participants will be sent home on Modified Philips Auto Servo Ventilation (ASV) study device. A wireless modem with oxygen saturation level (SPO2) connection will be connected to the Modified Philips ASV study device. The wireless modem with SPO2 connection is for device data collection/transmission purposes only that monitors the usage and performance of the device in the home-setting.

• The device setting should be set to the following:

• P max: 30

• EPAP min: 4

• Expiratory Positive Airway Pressure maximum (EPAPmax):15

• Pressure Support Minimum (PS min): 0

• Pressure Support Maximum (PS max): 15

• BiFlex (Bi-Level Flex): 2

• Rate: Auto

After 30 day Take Home Participants Will

• Return to the Sleep Lab

• Complete the end of study questionnaire

• Return all of the study equipment

Additional Take Home with the Modified Philips BiPAP ASV device:

• Participants may be asked to use the Modified Philips ASV study device for an additional 30 days if more data is needed for analysis. Participants will complete the same end of day questionnaire noted above.

After trial completion:

• When the Participant is done with the trial they will go back to using their own prescribed device.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Servo-Ventilation In-lab Polysomnography (PSG) Evaluation
• Actual Study Start Date: Nov 9, 2015
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: Jul 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Philips BiPAP AutoSV Advanced System One The Bi-Level Positive Airway Pressure system will be used and will be configured with these settings. P max: 30 EPAP min: 4 EPAPmax: 15 Pressure Support (PS) min: 0 Pressure Support (PS) max: 15 BiFlex: 2 Rate: Auto	Device: Philips BiPAP AutoSV Advanced System One; Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.
Experimental: Modified Philips BiPAP ASV The modified Philips BiPAP ASV will be configured with these settings P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto	Device: Modified Philips BiPAP ASV; This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.
Active Comparator: ResMed S7 VPAP Adapt This is an FDA approved device and the following settings will be administered: End-expiratory Pressure (EEP): 4 PSmin: 3 PSMax: 16	Device: ResMed S7 VPAP Adapt; This device is FDA approved and will be set to predetermined setting.
Active Comparator: ResMed S9 VPAP Adapt This is an FDA approved device and the following settings will be administered: EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 20 Max Ramp: Off	Device: ResMed S9 VPAP Adapt; This device is FDA approved and will be set to predetermined setting.

Outcome Measures

Primary Outcome Measures

1. Average Apnea Hypopnea Index Among Different Polysomnography Devices. [4 nights]

   The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to provide consent

• Age ≥ 21

• Currently prescribed servo ventilation therapy at home

• At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14 nights)

• Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of 5 or more

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 claustrophobic

• Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea

• Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).

• Participants requiring any kind of oxygen therapy

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

• Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona School of Medicine	Tucson	Arizona	United States	85723

Sponsors and Collaborators

• Philips Respironics

Investigators

• Principal Investigator: Sairam Parthasarathy, MD, University of Arizona

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 22, 2016

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT02808338
• Other Study ID Numbers: ST-1517-ALE-MS
• First Posted: Jun 21, 2016
• Last Update Posted: Mar 19, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Sleep Apnea Syndromes

Study Results

Participant Flow

Recruitment Details	A multi-site study that accrued over 2016 and into the middle of 2017.

Arm/Group Title	Screening
Arm/Group Description	All participants that consented to the study were considered for the participant flow. 15 participants were randomized to participate in the overnight in lab PSG's, these overnights were randomized to 1 of 4 interventions for each of the 4 overnights. This randomization scheme resulted in a large number of device sequences.
Period Title: Screening
STARTED	25
COMPLETED	15
NOT COMPLETED	10
Period Title: Screening
STARTED	15
Modified Philips BiPAP ASV	13
ResMed S7 VPAP Adapt	13
Philips BiPAP AutoSV Advanced System One	12
ResMed S9 VPAP Adapt	12
COMPLETED	13
NOT COMPLETED	2
Period Title: Screening
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Screening
Arm/Group Description	All participants that consented to the study.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 50%
>=65 years	10 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.3 (12.6)
Sex: Female, Male (Count of Participants)
Female	3 15%
Male	17 85%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	20 100%
Unknown or Not Reported	0 0%
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	0 0%
White	20 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Average Apnea Hypopnea Index Among Different Polysomnography Devices.
Description	The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.
Time Frame	4 nights

Outcome Measure Data

Analysis Population Description

1 participant was excluded because he did not meet the criteria to receive ASV.

Arm/Group Title	Philips BiPAP AutoSV Advanced System One	Modified Philips BiPAP ASV	ResMed S7 VPAP Adapt	ResMed S9 VPAP Adapt
Arm/Group Description	Philips Bilevel Postitive Airway Perssure (BiPAP) AutoSV Advanced System One: Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.	Modified Philips BiPAP AutoServoventilation (ASV): This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.	ResMed S7 Variable Positive Airway Pressure (VPAP) Adapt: This device is FDA approved and will be set to predetermined setting.	ResMed S9 VPAP Adapt: This device is FDA approved and will be set to predetermined setting.
Measure Participants	12	13	13	12
Mean (Standard Deviation) [events per hour]	18.4 (23.0)	25.4 (25)	24.1 (25.4)	19.2 (23.1)

Adverse Events

Time Frame	40 days
Arm/Group Title	Philips BiPAP AutoSV Advanced System One		Modified Philips BiPAP ASV		ResMed S7 VPAP Adapt		ResMed S9 VPAP Adapt		Take Home - Modified Philips BiPAP ASV
Arm/Group Description	The Bi-Level Positive Airway Pressure system will be used and will be configured with these settings. P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto Philips BiPAP AutoSV Advanced System One: Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.		The modified Philips BiPAP ASV will be configured with these settings P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto Modified Philips BiPAP ASV: This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.		This is an FDA approved device and the following settings will be administered: EEP: 4 PSmin: 3 PSMax: 16 ResMed S7 VPAP Adapt: This device is FDA approved and will be set to predetermined setting.		This is an FDA approved device and the following settings will be administered: EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 20 Max Ramp: Off ResMed S9 VPAP Adapt: This device is FDA approved and will be set to predetermined setting.		After the overnight PSGs participants took home the Modified Philips BiPAP ASV for 30 days.
All Cause Mortality
	Philips BiPAP AutoSV Advanced System One		Modified Philips BiPAP ASV		ResMed S7 VPAP Adapt		ResMed S9 VPAP Adapt		Take Home - Modified Philips BiPAP ASV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/13 (0%)		0/13 (0%)		0/12 (0%)		0/13 (0%)
Serious Adverse Events
	Philips BiPAP AutoSV Advanced System One		Modified Philips BiPAP ASV		ResMed S7 VPAP Adapt		ResMed S9 VPAP Adapt		Take Home - Modified Philips BiPAP ASV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/13 (0%)		0/13 (0%)		0/12 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Philips BiPAP AutoSV Advanced System One		Modified Philips BiPAP ASV		ResMed S7 VPAP Adapt		ResMed S9 VPAP Adapt		Take Home - Modified Philips BiPAP ASV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/13 (0%)		3/13 (23.1%)		0/12 (0%)		1/13 (7.7%)
Cardiac disorders
EKG abnormalities	0/12 (0%)	0	0/13 (0%)	0	1/13 (7.7%)	1	0/12 (0%)	0	0/13 (0%)	0
Paroxysmal Supraventricular Tachycardia	1/12 (8.3%)	1	0/13 (0%)	0	0/13 (0%)	0	0/12 (0%)	0	0/13 (0%)	0
non-sustained ventricular tachycardia	0/12 (0%)	0	0/13 (0%)	0	1/13 (7.7%)	1	0/12 (0%)	0	0/13 (0%)	0
Supraventricular Tachycardia	0/12 (0%)	0	0/13 (0%)	0	1/13 (7.7%)	1	0/12 (0%)	0	0/13 (0%)	0
Nervous system disorders
seziure	0/12 (0%)	0	0/13 (0%)	0	0/13 (0%)	0	0/12 (0%)	0	1/13 (7.7%)	1

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.