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

NCT ID: NCT00720213

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-07-31

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.

Conditions

Sleep Disordered Breathing; Sleep Apnea, Central

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3

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

Group Type: ACTIVE_COMPARATOR

Respironics BiPAP autoSV2

Intervention Type: DEVICE

Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Respironics BiPAP autoSV3

Intervention Type: DEVICE

Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2

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

Group Type: EXPERIMENTAL

Respironics BiPAP autoSV2

Intervention Type: DEVICE

Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Respironics BiPAP autoSV3

Intervention Type: DEVICE

Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Interventions

Respironics BiPAP autoSV2

Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Intervention Type: DEVICE

Respironics BiPAP autoSV3

Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Intervention Type: DEVICE

Other Intervention Names

Respironics BiPAP autoSV3 advanced

Eligibility Criteria

Inclusion Criteria

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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie Goodwin

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Shahrokh Javaheri, MD

Role: PRINCIPAL_INVESTIGATOR

Sleepcare Diagnostics

Rami Khayat, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State Univercity

Mark Goetting, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep Health

Paul Wylie, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Center for Sleep Medicine

Locations

University of Arizona

Tucson, Arizona, United States

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, United States

Mark G. Goetting

Portage, Michigan, United States

Ohio State University

Columbus, Ohio, United States

Sleepcare Diagnostics

Mason, Ohio, United States

Countries

United States

Other Identifiers

MR-0731-ASV3-MS

Identifier Type: -

Identifier Source: org_study_id