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Servo-Ventilation In-lab PSG Evaluation

NCT02808338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-03-19

Study results available
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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).

Conditions

  • Sleep Apnea Syndromes

Interventions

DEVICE

Philips BiPAP AutoSV Advanced System One

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.

DEVICE

Modified Philips BiPAP ASV

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

DEVICE

ResMed S7 VPAP Adapt

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

DEVICE

ResMed S9 VPAP Adapt

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

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • Sairam Parthasarathy, MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2017-05-31
Completion
2017-07-06
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 NCT02808338 on ClinicalTrials.gov