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NCT02683772 · ClinicalTrials.gov registry record · Phase 3
Astral VAPS AutoEPAP Clinical Trial
A Phase 3 study, sponsored by ResMed.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT02683772: Completed Phase 3 study, sponsored by ResMed.
NCT02683772 is a Phase 3 study that has completed, run by ResMed. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683772, a Phase 3 study, has completed, sponsored by ResMed.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE Astral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-04-15 |
| Est. Completion | 2017-07-06 |
| Phase | Phase 3 |
What the finished NCT02683772 record still lists
NCT02683772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Astral is the first listed.
NCT02683772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683772 about?
NCT02683772 is a clinical study titled "Astral VAPS AutoEPAP Clinical Trial". 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 ventilat...
What is the current status of trial NCT02683772?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2016-04-15. Estimated completion is 2017-07-06.
What interventions are being tested in trial NCT02683772?
The interventions under investigation include: Astral (DEVICE).
Who is sponsoring clinical trial NCT02683772?
This trial is sponsored by ResMed, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02683772's enrollment target sits among peer trials
42 1877th of 2000 higher than 124 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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