Servo-Ventilation In-lab PSG Evaluation

NCT02808338 | Completed Results FDA Device

• 1 other identifier: ST-1517-ALE-MS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Average Apnea Hypopnea Index Among Different Polysomnography Devices.

  The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.

  4 nights

Study Arms (4)

Philips BiPAP AutoSV Advanced System One

ACTIVE COMPARATOR

The Bi-Level Positive Airway Pressure system will be used and will be configured with these settings. P max: 30 EPAP min: 4 EPAPmax: 15 Pressure Support (PS) min: 0 Pressure Support (PS) max: 15 BiFlex: 2 Rate: Auto

Device: Philips BiPAP AutoSV Advanced System One

Modified Philips BiPAP ASV

EXPERIMENTAL

The modified Philips BiPAP ASV will be configured with these settings P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto

Device: Modified Philips BiPAP ASV

ResMed S7 VPAP Adapt

ACTIVE COMPARATOR

This is an FDA approved device and the following settings will be administered: End-expiratory Pressure (EEP): 4 PSmin: 3 PSMax: 16

Device: ResMed S7 VPAP Adapt

ResMed S9 VPAP Adapt

ACTIVE COMPARATOR

This is an FDA approved device and the following settings will be administered: EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 20 Max Ramp: Off

Device: ResMed S9 VPAP Adapt

Interventions

Philips BiPAP AutoSV Advanced System One DEVICE

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.

Philips BiPAP AutoSV Advanced System One

Modified Philips BiPAP ASV DEVICE

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

Modified Philips BiPAP ASV

ResMed S7 VPAP Adapt DEVICE

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

ResMed S7 VPAP Adapt

ResMed S9 VPAP Adapt DEVICE

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

ResMed S9 VPAP Adapt

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide consent
• Age ≥ 21
• Currently prescribed servo ventilation therapy at home
• At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14 nights)
• Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of 5 or more

You may not qualify if:

• Participants who are acutely ill, medically complicated or who are medically unstable
• Participants in whom PAP therapy is otherwise medically contraindicated
• Participants who are claustrophobic
• Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea
• Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
• Participants requiring any kind of oxygen therapy
• Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days
• Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI \> 10).

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

University of Arizona School of Medicine

Tucson, Arizona, 85723, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: Philips

jeremy.powers@philips.com

14125423669

Study Officials

• Sairam Parthasarathy, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 21, 2016
• Study Start: November 9, 2015
• Primary Completion: May 31, 2017
• Study Completion: July 6, 2017
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)