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Phase II not initiated for commercial reasons (no safety related issues)
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| Name | Class |
|---|---|
| Sir Charles Gairdner Hospital | OTHER |
| The University of Western Australia | OTHER |
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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)".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard ST Mode | Active Comparator | Participants underwent the first PSG study (Titration Night 1) on ST Mode ( prior to going on AutoEPAP iVAPS or Fixed EPAP iVAPS) whilst receiving their standard NIV therapy through the clinical trial device "Juno". During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy. |
|
| AutoEPAP iVAPS | Experimental | Participants underwent a PSG study on the AutoEPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first. |
|
| Fixed EPAP iVAPS | Active Comparator | Participants underwent a PSG study on the Fixed EPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juno | Device | Juno device set to ST mode with participant's current therapy settings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnoea-Hypopnoea Index (AHI) | The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Desaturation Index | Number of oxygen desaturations per hour of sleep | 1 night |
| Mean Oxygen Saturation | Mean oxygen saturation recorded in the total sleep time |
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Inclusion Criteria
Exclusion Criteria
Subjects not compliant on NIV (ie. < 4 hr/night)
Subjects with severe asthma
Subjects who are pregnant
Subjects on oxygen therapy (ie. >4 L/min)
Subjects with a tracheostomy
Subjects who are acutely ill, medically complicated or who are medically unstable
Subjects in whom PAP therapy is otherwise medically contraindicated
Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
Subjects who require ventilatory support during wakefulness
Subjects with the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, low blood pressure, cerebrospinal fluid leak, recent cranial surgery or trauma.
Subjects with severe developmental delay and who will not be able to follow tasks as instructed in the protocol.
Subjects who the investigator believes are unsuitable for inclusion because either:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Charles Gairdner Hospital | Perth | Western Australia | Australia | |||
| University of Western Australia |
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An overnight PSG retitration was performed by experienced sleep technologists to ensure current EPAP & other device settings were optimal. Titration took place with the device in ST mode with the patient's usual therapy setup. If the device settings were not optimal or if other problems such as patient-device dysynchrony, then the ventilator settings were adjusted by the sleep technologist based on current guidelines. Retitration studies were reviewed by at least 2 experienced sleep physicians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard ST Mode -> AutoEPAP iVAPS -> Fixed EPAP iVAPS | Night 1 Participants underwent the first PSG study on ST Mode receiving their standard NIV therapy through the clinical trial device "Juno". During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy. Night 2 Participants underwent a PSG study on the AutoEPAP iVAPS mode Night 3 Participants underwent a PSG study on the Fixed EPAP iVAPS mode |
| FG001 | Standard ST Mode -> FixedEPAP iVAPS -> AutoEPAP iVAPS Mode | Night 1 Participants underwent the first PSG study on ST Mode receiving their standard NIV therapy through the clinical trial device "Juno". During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy. Night 2 Participants underwent a PSG study on the FixedEPAP iVAPS mode Night 3 Participants underwent a PSG study on the AutoEPAP iVAPS mode |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participant Baseline | Participant's meeting the eligibility criteria had their baseline information collected at their Visit 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnoea-Hypopnoea Index (AHI) | The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | events/hour | 1 night |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard ST Mode | Standard ST mode. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Falls | General disorders | Systematic Assessment | Subject admitted to hospital following multiple falls which occurred after Titration Night 1. A rib fracture as a result of the SAE was noted at a later date. SAE and secondary event not related to study device or disease targeted by the trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Nigel McArdle & Prof Peter Eastwood | University of Western Australia | +61 8 9346 1706 | peter.eastwood@health.wa.gov.au |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D010845 | Obesity Hypoventilation Syndrome |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009468 | Neuromuscular Diseases |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
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| Juno | Device | Juno device set to AutoEPAP iVAPS mode. |
|
|
| Juno | Device | Juno device set to Fixed EPAP iVAPS mode. |
|
|
| 1 night |
| Time Spent Below 90% Oxygen Saturation | Time in minutes that the oxygen saturation was below 90% | 1 night |
| Mean Transcutaneous Carbon Dioxide (PtcCo2) | Transcutaneous Carbon Dioxide measurement (TcCO2) | 1 night |
| Sleep Duration | Time spent asleep | 1 Night |
| Sleep Efficacy | Sleep time divided by total time available for sleep | 1 Night |
| Sleep Latency-Wake After Sleep Onset Time | Time awake in minutes after initial sleep onset | 1 Night |
| Total Sleep Time Spent in Each Sleep Stage | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) | 1 Night |
| Number of Respiratory Event Related Arousals/ Hour | Total number of respiratory event related arousals/hr over the entire sleep period | 1 Night |
| Number of Spontaneous Arousals/Hour | Number of spontaneous arousals/hr occurring over the entire total sleep time | 1 Night |
| Perth |
| Western Australia |
| Australia |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| AutoEPAP iVAPS |
Participants underwent a PSG study on the AutoEPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first. |
| OG002 | FixedEPAP iVAPS | Participants underwent a PSG study on the Fixed EPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first. |
|
|
| Secondary | Oxygen Desaturation Index | Number of oxygen desaturations per hour of sleep | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | events/hour | 1 night |
|
|
|
| Secondary | Mean Oxygen Saturation | Mean oxygen saturation recorded in the total sleep time | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | percentage of oxygen saturation | 1 night |
|
|
|
| Secondary | Time Spent Below 90% Oxygen Saturation | Time in minutes that the oxygen saturation was below 90% | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | Minutes | 1 night |
|
|
|
| Secondary | Mean Transcutaneous Carbon Dioxide (PtcCo2) | Transcutaneous Carbon Dioxide measurement (TcCO2) | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | mmHg | 1 night |
|
|
|
| Secondary | Sleep Duration | Time spent asleep | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | Minutes | 1 Night |
|
|
|
| Secondary | Sleep Efficacy | Sleep time divided by total time available for sleep | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | percentage of total recorded time | 1 Night |
|
|
|
| Secondary | Sleep Latency-Wake After Sleep Onset Time | Time awake in minutes after initial sleep onset | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | Minutes | 1 Night |
|
|
|
| Secondary | Total Sleep Time Spent in Each Sleep Stage | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | Minutes | 1 Night |
|
|
|
| Secondary | Number of Respiratory Event Related Arousals/ Hour | Total number of respiratory event related arousals/hr over the entire sleep period | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | arousals/hr | 1 Night |
|
|
|
| Secondary | Number of Spontaneous Arousals/Hour | Number of spontaneous arousals/hr occurring over the entire total sleep time | Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD). | Posted | Mean | Standard Deviation | arousals/hr | 1 Night |
|
|
|
| 25 |
| 0 |
| 25 |
| 4 |
| 25 |
| EG001 | AutoEPAP iVAPS | AutoEPAP iVAPS. | 0 | 25 | 1 | 25 | 2 | 25 |
| EG002 | FixedEPAP iVAPS | FixedEPAP iVAPS. | 0 | 25 | 0 | 25 | 2 | 25 |
|
| Headache | General disorders | Non-systematic Assessment |
|
| AEROPHAGIA | Gastrointestinal disorders | Non-systematic Assessment |
|
| SORE BACK | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SKIN ABRASION TO CHIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| MILD CHEST INFECTION | Infections and infestations | Non-systematic Assessment |
|
The Sponsor has the right to
within 40 days of the proposed publication being released to those not bound by confidentiality obligations.
| D001049 | Apnea |
| D007040 | Hypoventilation |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Time spent in N3 Sleep |
|
| Time spent in REM Sleep |
|