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

Philips

Status: Completed

Conditions: Sleep Disordered Breathing; Sleep Apnea, Central

Treatments: Device: Respironics BiPAP autoSV3; Device: Respironics BiPAP autoSV2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00720213

MR-0731-ASV3-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3

Active Comparator group

Description:

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

Treatment:

Device: Respironics BiPAP autoSV2

Device: Respironics BiPAP autoSV3

Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2

Experimental group

Description:

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

Treatment:

Device: Respironics BiPAP autoSV2

Device: Respironics BiPAP autoSV3