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Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device (AUTOSV3)

Primary Purpose

Sleep Disordered Breathing, Sleep Apnea, Central

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respironics BiPAP autoSV2
Respironics BiPAP autoSV3
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Pre-Study Inclusion Criteria:

  • Age 21-80
  • Ability to provide consent
  • Documentation of medical stability by investigator

Enrollment Inclusion Criteria:

• Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5

or

• Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.

Exclusion Criteria:

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

    • Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
    • Participants in whom PAP therapy is otherwise medically contraindicated.
    • Participants who are unwilling to wear CPAP
    • Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
    • 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 (PLM Arousal Index > 15).
    • Participants who are unwilling to participate in the study.

Sites / Locations

  • University of Arizona
  • Arkansas Center for Sleep Medicine
  • Mark G. Goetting
  • Ohio State University
  • Sleepcare Diagnostics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3

Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2

Arm Description

Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.

Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.

Secondary Outcome Measures

Apnea Hypopnea Index- REM and NREM
The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement) A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM.
Central Apnea Index
The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort. A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour.
Obstructive Apnea Index
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway. A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour.
Mixed Apnea Index
Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour.
Hypopnea Index
Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour.
Sleep Onset Latency
Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.
Rapid Eye Movement (REM) Onset Latency
Rapid eye movement latency is the time from the sleep onset to the first epoch of REM sleep; therefore, it depends on the patient's sleep latency.
Wake After Sleep Onset
Wake after sleep onset refers to periods of wakefulness occurring after defined sleep onset. This was calculated by adding the total number of minutes the participant was awake after sleep onset.
Total Sleep Time
Total sleep time is the total time the participant was asleep after sleep onset. This is calculated by adding the total number of minutes the participant was asleep during the night after sleep onset.
Sleep Efficiency
Sleep efficiency is a measure of how much a participant slept over the night. This is calculated by comparing the total sleep time and the total recording time * 100.
Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.
These measures are the amount of time patients spent in each stage of sleep in minutes.
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']
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, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)
Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.
Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.
This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.

Full Information

First Posted
July 18, 2008
Last Updated
January 4, 2019
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT00720213
Brief Title
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
Acronym
AUTOSV3
Official Title
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) 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.
Detailed Description
This study was conducted to evaluate the therapeutic performance of a new auto Servo Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed airway apnea, a modified auto backup rate which is proportional to subject's baseline breathing rate, and a variable inspiratory support. Our primary aim was to compare the performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA). Study Design: A prospective, multicenter, randomized, controlled trial. Setting: Five sleep laboratories in the United States. Participants: Thirty-seven participants were included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Sleep Apnea, Central

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.
Arm Title
Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2
Arm Type
Experimental
Arm Description
Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.
Intervention Type
Device
Intervention Name(s)
Respironics BiPAP autoSV2
Intervention Description
Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Intervention Type
Device
Intervention Name(s)
Respironics BiPAP autoSV3
Other Intervention Name(s)
Respironics BiPAP autoSV3 advanced
Intervention Description
Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.
Time Frame
2 nights
Secondary Outcome Measure Information:
Title
Apnea Hypopnea Index- REM and NREM
Description
The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement) A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM.
Time Frame
2 nights
Title
Central Apnea Index
Description
The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort. A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour.
Time Frame
2 nights
Title
Obstructive Apnea Index
Description
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway. A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour.
Time Frame
2 nights
Title
Mixed Apnea Index
Description
Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour.
Time Frame
2 nights
Title
Hypopnea Index
Description
Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour.
Time Frame
2 nights
Title
Sleep Onset Latency
Description
Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.
Time Frame
2 nights
Title
Rapid Eye Movement (REM) Onset Latency
Description
Rapid eye movement latency is the time from the sleep onset to the first epoch of REM sleep; therefore, it depends on the patient's sleep latency.
Time Frame
2 nights
Title
Wake After Sleep Onset
Description
Wake after sleep onset refers to periods of wakefulness occurring after defined sleep onset. This was calculated by adding the total number of minutes the participant was awake after sleep onset.
Time Frame
2 nights
Title
Total Sleep Time
Description
Total sleep time is the total time the participant was asleep after sleep onset. This is calculated by adding the total number of minutes the participant was asleep during the night after sleep onset.
Time Frame
2 nights
Title
Sleep Efficiency
Description
Sleep efficiency is a measure of how much a participant slept over the night. This is calculated by comparing the total sleep time and the total recording time * 100.
Time Frame
2 nights
Title
Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.
Description
These measures are the amount of time patients spent in each stage of sleep in minutes.
Time Frame
2 nights
Title
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
Time Frame
2 nights
Title
Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']
Description
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, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.
Time Frame
2 nights
Title
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)
Description
Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.
Time Frame
2 nights
Title
Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.
Description
This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.
Time Frame
2 nights
Title
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
Description
The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.
Time Frame
2 nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pre-Study Inclusion Criteria: Age 21-80 Ability to provide consent Documentation of medical stability by investigator Enrollment Inclusion Criteria: • Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5 or • Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration. Exclusion Criteria: • Participants who are acutely ill, medically complicated or who are medically unstable. Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential). Participants in whom PAP therapy is otherwise medically contraindicated. Participants who are unwilling to wear CPAP Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights. 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 (PLM Arousal Index > 15). Participants who are unwilling to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Goodwin
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahrokh Javaheri, MD
Organizational Affiliation
Sleepcare Diagnostics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rami Khayat, MD
Organizational Affiliation
Ohio State Univercity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Goetting, MD
Organizational Affiliation
Sleep Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Wylie, MD
Organizational Affiliation
Arkansas Center for Sleep Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Center for Sleep Medicine
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mark G. Goetting
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Sleepcare Diagnostics
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device

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