The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- ResMed
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Apnoea-Hypopnoea Index (AHI)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Apnoea-Hypopnoea Index (AHI)
Time Frame: 1 night
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Secondary Outcomes
- Mean Oxygen Saturation(1 night)
- Total Sleep Time Spent in Each Sleep Stage(1 Night)
- Number of Respiratory Event Related Arousals/ Hour(1 Night)
- Oxygen Desaturation Index(1 night)
- Sleep Duration(1 Night)
- Sleep Efficacy(1 Night)
- Sleep Latency-Wake After Sleep Onset Time(1 Night)
- Time Spent Below 90% Oxygen Saturation(1 night)
- Number of Spontaneous Arousals/Hour(1 Night)
- Mean Transcutaneous Carbon Dioxide (PtcCo2)(1 night)