Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease, Obesity Hypoventilation Syndrome, Respiratory Insufficiency, Upper Airway Obstruction
Conditions
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.
Interventions
DEVICEJuno
Juno device set to ST mode with participant's current therapy settings.
Sponsors
Sir Charles Gairdner Hospital
The University of Western Australia
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject has ability to provide written informed consent * Subject aged ≥18 years old * Subject has a diagnosis of COPD, OHS or NMD with sleep hypoventilation (historical PtCO2 increase overnight ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg) * Subject is currently using non-invasive ventilation for ≥ 3 months * Subject with an AHI ≥ 5 hr. (as documented in diagnostic or pressure determination sleep study report)
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: * they do not comprehend English * they are unable or unwilling to provide written informed consent * they are physically unable to comply with the protocol * they are unsuitable to participate in the trial for any other reason in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnoea-Hypopnoea Index (AHI) | 1 night | The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Oxygen Saturation | 1 night | Mean oxygen saturation recorded in the total sleep time |
| Time Spent Below 90% Oxygen Saturation | 1 night | Time in minutes that the oxygen saturation was below 90% |
| Mean Transcutaneous Carbon Dioxide (PtcCo2) | 1 night | Transcutaneous Carbon Dioxide measurement (TcCO2) |
| Sleep Duration | 1 Night | Time spent asleep |
| Oxygen Desaturation Index | 1 night | Number of oxygen desaturations per hour of sleep |
| Sleep Latency-Wake After Sleep Onset Time | 1 Night | Time awake in minutes after initial sleep onset |
| Total Sleep Time Spent in Each Sleep Stage | 1 Night | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) |
| Number of Respiratory Event Related Arousals/ Hour | 1 Night | Total number of respiratory event related arousals/hr over the entire sleep period |
| Number of Spontaneous Arousals/Hour | 1 Night | Number of spontaneous arousals/hr occurring over the entire total sleep time |
| Sleep Efficacy | 1 Night | Sleep time divided by total time available for sleep |
Countries
Australia
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Participant Baseline Participant's meeting the eligibility criteria had their baseline information collected at their Visit 1. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Participant Baseline |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Region of Enrollment Australia | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 4 / 25 | 2 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 | 0 / 25 |
Outcome results
Primary
Apnoea-Hypopnoea Index (AHI)
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
Time frame: 1 night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Apnoea-Hypopnoea Index (AHI) | 3.87 events/hour | Standard Deviation 6.19 |
| AutoEPAP iVAPS | Apnoea-Hypopnoea Index (AHI) | 3.57 events/hour | Standard Deviation 3.76 |
| FixedEPAP iVAPS | Apnoea-Hypopnoea Index (AHI) | 4.09 events/hour | Standard Deviation 5.54 |
Secondary
Mean Oxygen Saturation
Mean oxygen saturation recorded in the total sleep time
Time frame: 1 night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Mean Oxygen Saturation | 93.99 percentage of oxygen saturation | Standard Deviation 1.97 |
| AutoEPAP iVAPS | Mean Oxygen Saturation | 94.01 percentage of oxygen saturation | Standard Deviation 1.89 |
| FixedEPAP iVAPS | Mean Oxygen Saturation | 94.33 percentage of oxygen saturation | Standard Deviation 2.12 |
Secondary
Mean Transcutaneous Carbon Dioxide (PtcCo2)
Transcutaneous Carbon Dioxide measurement (TcCO2)
Time frame: 1 night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Mean Transcutaneous Carbon Dioxide (PtcCo2) | 45.73 mmHg | Standard Deviation 6.1 |
| AutoEPAP iVAPS | Mean Transcutaneous Carbon Dioxide (PtcCo2) | 47.44 mmHg | Standard Deviation 5.04 |
| FixedEPAP iVAPS | Mean Transcutaneous Carbon Dioxide (PtcCo2) | 46.78 mmHg | Standard Deviation 6.1 |
Secondary
Number of Respiratory Event Related Arousals/ Hour
Total number of respiratory event related arousals/hr over the entire sleep period
Time frame: 1 Night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Number of Respiratory Event Related Arousals/ Hour | 5.17 arousals/hr | Standard Deviation 5.85 |
| AutoEPAP iVAPS | Number of Respiratory Event Related Arousals/ Hour | 5.67 arousals/hr | Standard Deviation 4.14 |
| FixedEPAP iVAPS | Number of Respiratory Event Related Arousals/ Hour | 6.54 arousals/hr | Standard Deviation 7.69 |
Secondary
Number of Spontaneous Arousals/Hour
Number of spontaneous arousals/hr occurring over the entire total sleep time
Time frame: 1 Night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Number of Spontaneous Arousals/Hour | 31.41 arousals/hr | Standard Deviation 21.09 |
| AutoEPAP iVAPS | Number of Spontaneous Arousals/Hour | 29.21 arousals/hr | Standard Deviation 18.16 |
| FixedEPAP iVAPS | Number of Spontaneous Arousals/Hour | 31.92 arousals/hr | Standard Deviation 23.67 |
Secondary
Oxygen Desaturation Index
Number of oxygen desaturations per hour of sleep
Time frame: 1 night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Oxygen Desaturation Index | 5.06 events/hour | Standard Deviation 6.18 |
| AutoEPAP iVAPS | Oxygen Desaturation Index | 4.45 events/hour | Standard Deviation 4.15 |
| FixedEPAP iVAPS | Oxygen Desaturation Index | 5.70 events/hour | Standard Deviation 8.96 |
Secondary
Sleep Duration
Time spent asleep
Time frame: 1 Night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Sleep Duration | 333.4 Minutes | Standard Deviation 86.06 |
| AutoEPAP iVAPS | Sleep Duration | 331.7 Minutes | Standard Deviation 109.08 |
| FixedEPAP iVAPS | Sleep Duration | 340.9 Minutes | Standard Deviation 110.43 |
Secondary
Sleep Efficacy
Sleep time divided by total time available for sleep
Time frame: 1 Night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Sleep Efficacy | 64 percentage of total recorded time | Standard Deviation 15 |
| AutoEPAP iVAPS | Sleep Efficacy | 66 percentage of total recorded time | Standard Deviation 15 |
| FixedEPAP iVAPS | Sleep Efficacy | 66 percentage of total recorded time | Standard Deviation 18 |
Secondary
Sleep Latency-Wake After Sleep Onset Time
Time awake in minutes after initial sleep onset
Time frame: 1 Night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Sleep Latency-Wake After Sleep Onset Time | 22.56 Minutes | Standard Deviation 17.41 |
| AutoEPAP iVAPS | Sleep Latency-Wake After Sleep Onset Time | 29.98 Minutes | Standard Deviation 43.19 |
| FixedEPAP iVAPS | Sleep Latency-Wake After Sleep Onset Time | 28.12 Minutes | Standard Deviation 29.98 |
Secondary
Time Spent Below 90% Oxygen Saturation
Time in minutes that the oxygen saturation was below 90%
Time frame: 1 night
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ST Mode | Time Spent Below 90% Oxygen Saturation | 37.26 Minutes | Standard Deviation 78.18 |
| AutoEPAP iVAPS | Time Spent Below 90% Oxygen Saturation | 37.03 Minutes | Standard Deviation 87.75 |
| FixedEPAP iVAPS | Time Spent Below 90% Oxygen Saturation | 34.31 Minutes | Standard Deviation 100.25 |
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)
Time frame: 1 Night
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard ST Mode | Total Sleep Time Spent in Each Sleep Stage | Time spent in N1 Sleep | 75.68 Minutes | Standard Deviation 33.88 |
| Standard ST Mode | Total Sleep Time Spent in Each Sleep Stage | Time spent in N2 Sleep | 186.9 Minutes | Standard Deviation 67.14 |
| Standard ST Mode | Total Sleep Time Spent in Each Sleep Stage | Time spent in N3 Sleep | 27.36 Minutes | Standard Deviation 26.43 |
| Standard ST Mode | Total Sleep Time Spent in Each Sleep Stage | Time spent in REM Sleep | 44.04 Minutes | Standard Deviation 26.36 |
| AutoEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in REM Sleep | 45.30 Minutes | Standard Deviation 24.99 |
| AutoEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in N1 Sleep | 76.62 Minutes | Standard Deviation 45.18 |
| AutoEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in N3 Sleep | 37.38 Minutes | Standard Deviation 31.26 |
| AutoEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in N2 Sleep | 172.3 Minutes | Standard Deviation 74.08 |
| FixedEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in REM Sleep | 54.00 Minutes | Standard Deviation 44.1 |
| FixedEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in N2 Sleep | 174.9 Minutes | Standard Deviation 85.09 |
| FixedEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in N3 Sleep | 29.98 Minutes | Standard Deviation 24.73 |
| FixedEPAP iVAPS | Total Sleep Time Spent in Each Sleep Stage | Time spent in N1 Sleep | 82.08 Minutes | Standard Deviation 46.31 |