Trials / Terminated
TerminatedNCT02317042
Juno Perth Clinical Trial
The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- ResMed · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".
Detailed description
Phase I: AutoEPAP iVAPS will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (Fixed EPAP iVAPS)" in current NIV users with respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD),Obesity Hypoventilation Syndrome (OHS) or Neuromuscular Disease (NMD). Patients will spend a total of 3 nights in the sleep laboratory in the three modes described above. The apnoea-hypopnoea index will be the primary outcome measure. Phase II: AutoEPAP iVAPS will be compared to ST mode over a period of 7 nights in the patients' home. The mean EPAP setting of each device will be the primary outcome measure.
Conditions
- Respiratory Insufficiency
- Obesity Hypoventilation Syndrome
- Chronic Obstructive Pulmonary Disease (COPD)
- Neuromuscular Disease
- Upper Airway Obstruction
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Juno | Juno device set to ST mode with participant's current therapy settings. |
| DEVICE | Juno | Juno device set to AutoEPAP iVAPS mode. |
| DEVICE | Juno | Juno device set to Fixed EPAP iVAPS mode. |
Timeline
- Start date
- 2015-05-29
- Primary completion
- 2015-11-01
- Completion
- 2015-11-29
- First posted
- 2014-12-15
- Last updated
- 2021-06-08
- Results posted
- 2021-06-08
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT02317042. Inclusion in this directory is not an endorsement.