Back to results

Astral VAPS AutoEPAP Clinical Trial

Primary Purpose

Upper Airway Obstruction, Respiratory Insufficiency, Respiratory Failure

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Astral

About this trial

This is an interventional treatment trial for Upper Airway Obstruction focused on measuring NIV, NIPPV, ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for the study are:

Participant has ability to provide written informed consent
Participants aged ≥18 years old
Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months
Participants with a previously documented AHI ≥ 5/hr
Participants with a recently (≤ 12 months ago) reviewed EPAP setting

Exclusion criteria for the study are:

Participants are not compliant on NIPPV (e.g. < 4 hr/night)
Participants who are pregnant
Participants on oxygen therapy ≥5 L/min
Participants with an invasive interface (e.g. tracheostomy)
Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation
Participants who are acutely ill, medically complicated or who are medically unstable
Participants in whom NIPPV therapy is otherwise medically contraindicated
Participants who have had surgery of the upper airway, nose, sinus, 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.
Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma.
Participant does not comprehend English
Participant is unable or unwilling to provide written informed consent
Participant is physically and/or mentally unable to comply with the protocol
Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator

Sites / Locations

University of California, San Diego
National Jewish Health
Lisa F. Wolfe, MD
Temple University
University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iVAPS with AutoEPAP

iVAPS with manual EPAP

Arm Description

This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night.

This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night.

Outcomes

Primary Outcome Measures

Oxygen Desaturation Index 4% (ODI4%)

Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP

Secondary Outcome Measures

Sleep Efficiency (%)

To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)

Apnea Hypopnea Index (AHI)

To assess sleep-breathing parameters between groups using mean AHI (#events/hour)

Nadir Arterial Oxygen Saturation (SpO2)

To assess Sleep-breathing parameters between groups using mean SpO2 (%)

Arterial Carbon Dioxide (PCO2)

To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)

Full Information

NCT ID

NCT02683772

First Posted

February 3, 2016

Last Updated

July 18, 2019

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT02683772

Brief Title

Astral VAPS AutoEPAP Clinical Trial

Official Title

The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 15, 2016 (Actual)

Primary Completion Date

March 1, 2017 (Actual)

Study Completion Date

July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Airway Obstruction, Respiratory Insufficiency, Respiratory Failure

Keywords

NIV, NIPPV, ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Participant

Masking Description

Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iVAPS with AutoEPAP

Arm Type

Experimental

Arm Description

This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night.

Arm Title

iVAPS with manual EPAP

Arm Type

Active Comparator

Arm Description

This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night.

Intervention Type

Device

Intervention Name(s)

Astral

Intervention Description

Astral ventilator

Primary Outcome Measure Information:

Title

Oxygen Desaturation Index 4% (ODI4%)

Description

Time Frame

Overnight, up to 8 hrs on nights 1 and 2

Secondary Outcome Measure Information:

Title

Sleep Efficiency (%)

Description

To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)

Time Frame

Overnight, up to 8 hrs on nights 1 and 2

Title

Apnea Hypopnea Index (AHI)

Description

To assess sleep-breathing parameters between groups using mean AHI (#events/hour)

Time Frame

Overnight, up 8 hrs on night 1 and 2

Title

Nadir Arterial Oxygen Saturation (SpO2)

Description

To assess Sleep-breathing parameters between groups using mean SpO2 (%)

Time Frame

Overnight, up 8 hrs on night 1 and 2

Title

Arterial Carbon Dioxide (PCO2)

Description

To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)

Time Frame

Overnight, up 8 hrs on night 1 and 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria for the study are: Participant has ability to provide written informed consent Participants aged ≥18 years old Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg) Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months Participants with a previously documented AHI ≥ 5/hr Participants with a recently (≤ 12 months ago) reviewed EPAP setting Exclusion criteria for the study are: Participants are not compliant on NIPPV (e.g. < 4 hr/night) Participants who are pregnant Participants on oxygen therapy ≥5 L/min Participants with an invasive interface (e.g. tracheostomy) Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation Participants who are acutely ill, medically complicated or who are medically unstable Participants in whom NIPPV therapy is otherwise medically contraindicated Participants who have had surgery of the upper airway, nose, sinus, 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. Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma. Participant does not comprehend English Participant is unable or unwilling to provide written informed consent Participant is physically and/or mentally unable to comply with the protocol Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Wolfe, MD

Organizational Affiliation

Northwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

National Jewish Health

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Lisa F. Wolfe, MD

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17565016

Citation

Budweiser S, Jorres RA, Riedl T, Heinemann F, Hitzl AP, Windisch W, Pfeifer M. Predictors of survival in COPD patients with chronic hypercapnic respiratory failure receiving noninvasive home ventilation. Chest. 2007 Jun;131(6):1650-8. doi: 10.1378/chest.06-2124.

Results Reference

background

PubMed Identifier

11296176

Citation

Masa JF, Celli BR, Riesco JA, Hernandez M, Sanchez De Cos J, Disdier C. The obesity hypoventilation syndrome can be treated with noninvasive mechanical ventilation. Chest. 2001 Apr;119(4):1102-7. doi: 10.1378/chest.119.4.1102.

Results Reference

background

PubMed Identifier

670014

Citation

Remmers JE, deGroot WJ, Sauerland EK, Anch AM. Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol. 1978 Jun;44(6):931-8. doi: 10.1152/jappl.1978.44.6.931. No abstract available.

Results Reference

background

PubMed Identifier

16299118

Citation

Ward S, Chatwin M, Heather S, Simonds AK. Randomised controlled trial of non-invasive ventilation (NIV) for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia. Thorax. 2005 Dec;60(12):1019-24. doi: 10.1136/thx.2004.037424.

Results Reference

background

PubMed Identifier

12826594

Citation

Laghi F, Tobin MJ. Disorders of the respiratory muscles. Am J Respir Crit Care Med. 2003 Jul 1;168(1):10-48. doi: 10.1164/rccm.2206020.

Results Reference

background

PubMed Identifier

31120585

Citation

Suh ES, Murphy PB. Auto-titration of EPAP during NIV: A better night's sleep? Respirology. 2019 Dec;24(12):1132-1133. doi: 10.1111/resp.13587. Epub 2019 May 23. No abstract available.

Results Reference

derived

PubMed Identifier

31012225

Citation

Orr JE, Coleman J, Criner GJ, Sundar KM, Tsai SC, Benjafield AV, Crocker ME, Willes L, Malhotra A, Owens RL, Wolfe LF. Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial. Respirology. 2019 Dec;24(12):1204-1211. doi: 10.1111/resp.13546. Epub 2019 Apr 22.

Results Reference

derived

Learn more about this trial

Astral VAPS AutoEPAP Clinical Trial

We'll reach out to this number within 24 hrs