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Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

NCT01241604 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-04-09

Study results available
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Summary

This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T 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

Interventions

DEVICE

BiPAP S/T

Mechanical Non-invasive Ventilation

DEVICE

BiPAP Auto SV3

Auto Servo Ventilation Device

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • Brydon Grant, MD · Medical Director of Med One Medical

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
2009-01-31
Primary Completion
2009-07-31
Completion
2009-07-31
FDA Device
Yes

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 NCT01241604 on ClinicalTrials.gov