CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Philips BiPAP AutoSV Advanced System One +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02808338
NCT02808338N/ACompleted

Servo-Ventilation In-lab Polysomnography (PSG) Evaluation

Philips Respironics·interventional·Posted Jun 21, 2016·Updated Mar 19, 2019

In Brief

A clinical study evaluating Philips BiPAP AutoSV Advanced System One, Modified Philips BiPAP ASV, and 2 other interventions for Sleep Apnea Syndromes. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents instability and collapse. With a stable and patent airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing. Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. The main features of the Auto SV mode include: * Normalization of ventilation by automatically adjusting Inspiratory Positive Airway Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased to help stabilize the ventilation. * Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing. * Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive events. Several manufacturers produce these types of devices. The algorithms used to determine the IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 21, 2016
Enrollment StartNov 9, 2015
Primary CompletionMay 31, 2017
Study CompletionJul 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.0 years ago

Interventions

Philips BiPAP AutoSV Advanced System Onedevice

Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.

Modified Philips BiPAP ASVdevice

This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.

ResMed S7 VPAP Adaptdevice

This device is FDA approved and will be set to predetermined setting.

ResMed S9 VPAP Adaptdevice

This device is FDA approved and will be set to predetermined setting.