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

NCT00720213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-01-29

Study results available
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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.

Conditions

  • Sleep Disordered Breathing
  • Sleep Apnea, Central

Interventions

DEVICE

Respironics BiPAP autoSV2

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

DEVICE

Respironics BiPAP autoSV3

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

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • Jamie Goodwin · University of Arizona

  • Shahrokh Javaheri, MD · Sleepcare Diagnostics

  • Rami Khayat, MD · Ohio State Univercity

  • Mark Goetting, MD · Sleep Health

  • Paul Wylie, MD · Arkansas Center for Sleep Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00720213 on ClinicalTrials.gov