AzTrials
AzTrials

Upper Airway ObstructionPhase 3NCT02683772

Astral VAPS AutoEPAP Clinical Trial

A Phase 3 study testing Astral in people with Upper Airway Obstruction and Respiratory Insufficiency, run by ResMed at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Astral
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
5 sitesUnited States
Study dates
15 Apr 2016to 6 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Lisa F. Wolfe, MD

    Chicago, Illinois, 60611

  • National Jewish Health

    Denver, Colorado, 80206

  • University of California, San Diego

    La Jolla, California, 92037

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

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.

Being tested
Astral
Keywords
NIV, NIPPV, ventilation
Medical subject headings
Airway Obstruction, Respiratory Insufficiency, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AstralDevice

    Astral ventilator

Study groups in NCT02683772
Study groupRoleWhat they receive
iVAPS with AutoEPAPExperimentalThis 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.
Receives: Device: Astral
iVAPS with manual EPAPActive comparatorThis 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.
Receives: Device: Astral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Overnight, up to 8 hrs on nights 1 and 2

Secondary outcomes (4)

  1. Sleep Efficiency (%)

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

    Measured: Overnight, up to 8 hrs on nights 1 and 2

  2. Apnea Hypopnea Index (AHI)

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

    Measured: Overnight, up 8 hrs on night 1 and 2

  3. Nadir Arterial Oxygen Saturation (SpO2)

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

    Measured: Overnight, up 8 hrs on night 1 and 2

  4. Arterial Carbon Dioxide (PCO2)

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

    Measured: Overnight, up 8 hrs on night 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2016 (estimated)
  2. Study start15 Apr 2016
  3. Primary completion1 Mar 2017
  4. Study completion6 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02683772
Sponsor's protocol ID
MA-15-12-15
Status last verified
Jul 2019
First submitted
3 Feb 2016
Last updated
26 Jul 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 17565016

  • 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.

    PubMed 11296176

  • 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.

    PubMed 670014

  • 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.

    PubMed 16299118

  • 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.

    PubMed 12826594

  • 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.

    PubMed 31120585

  • 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.

    PubMed 31012225

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Astral in people with Upper Airway Obstruction and Respiratory Insufficiency, run by ResMed at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Desaturation Index 4% (ODI4%) (time frame: Overnight, up to 8 hrs on nights 1 and 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02683772, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in