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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iVAPS with AutoEPAP | Experimental | This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night. |
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| iVAPS with manual EPAP | Active Comparator | This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astral | Device | Astral ventilator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Desaturation Index 4% (ODI4%) | 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 | Overnight, up to 8 hrs on nights 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency (%) | To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time) | Overnight, up to 8 hrs on nights 1 and 2 |
| Apnea Hypopnea Index (AHI) |
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Inclusion criteria for the study are:
Exclusion criteria for the study are:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Wolfe, MD | Northwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17565016 | Background | Budweiser S, Jorres RA, Riedl T, Heinemann F, Hitzl AP, Windisch W, Pfeifer M. Predictors of survival in COPD patients with chronic hypercapnic respiratory failure receiving noninvasive home ventilation. Chest. 2007 Jun;131(6):1650-8. doi: 10.1378/chest.06-2124. | |
| 11296176 | Background | Masa JF, Celli BR, Riesco JA, Hernandez M, Sanchez De Cos J, Disdier C. The obesity hypoventilation syndrome can be treated with noninvasive mechanical ventilation. Chest. 2001 Apr;119(4):1102-7. doi: 10.1378/chest.119.4.1102. |
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43 patients consented for this study. One patient did not meet criteria. 42 patients were randomized and began the first study PSG night. 3 patients were found to be ineligible due to I/E criteria not met. Site erroneously placed patient on ST mode for one of the PSG study nights. Thus, there were 38 patients that were analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | iVAPS With AutoEPAP, Then iVAPS With Manual EPAP | This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with AutoEPAP first, and the second night iVAPS with manual EPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required. |
| FG001 | iVAPS With Manual EPAP, Then iVAPS With AutoEPAP | This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with manual EPAP first, and the second night iVAPS with AutoEPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Total | This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Oxygen Desaturation Index 4% (ODI4%) | 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 | This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients. | Posted | Mean | Standard Deviation | events per hour | Overnight, up to 8 hrs on nights 1 and 2 |
|
Adverse Event data were collected for each patient enrolled into the study. AE data was collected from signing of Informed Consent Form until the patient's final completion date (PSG #2).
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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 | iVAPS With AutoEPAP | This is a crossover study. There were 42 patients randomized in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. Adverse Event data were collected for all 42 enrolled patients. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient woke up with an asthma exacerbation at 4:37am. Patient utilized her normal home routine treatment. This event was determined to be 'not related' to the device or study treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen Crocker, Manager Medical Affairs | ResMed | 8588366653 | maureen.crocker@resmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2016 | Mar 21, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2016 | Mar 21, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
To assess sleep-breathing parameters between groups using mean AHI (#events/hour)
| Overnight, up 8 hrs on night 1 and 2 |
| Nadir Arterial Oxygen Saturation (SpO2) | To assess Sleep-breathing parameters between groups using mean SpO2 (%) | Overnight, up 8 hrs on night 1 and 2 |
| Arterial Carbon Dioxide (PCO2) | To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg) | Overnight, up 8 hrs on night 1 and 2 |
| Denver |
| Colorado |
| 80206 |
| United States |
| Lisa F. Wolfe, MD | Chicago | Illinois | 60611 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| 670014 | Background | Remmers JE, deGroot WJ, Sauerland EK, Anch AM. Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol. 1978 Jun;44(6):931-8. doi: 10.1152/jappl.1978.44.6.931. No abstract available. |
| 16299118 | Background | Ward S, Chatwin M, Heather S, Simonds AK. Randomised controlled trial of non-invasive ventilation (NIV) for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia. Thorax. 2005 Dec;60(12):1019-24. doi: 10.1136/thx.2004.037424. |
| 12826594 | Background | Laghi F, Tobin MJ. Disorders of the respiratory muscles. Am J Respir Crit Care Med. 2003 Jul 1;168(1):10-48. doi: 10.1164/rccm.2206020. |
| 31120585 | Derived | Suh ES, Murphy PB. Auto-titration of EPAP during NIV: A better night's sleep? Respirology. 2019 Dec;24(12):1132-1133. doi: 10.1111/resp.13587. Epub 2019 May 23. No abstract available. |
| 31012225 | Derived | Orr JE, Coleman J, Criner GJ, Sundar KM, Tsai SC, Benjafield AV, Crocker ME, Willes L, Malhotra A, Owens RL, Wolfe LF. Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial. Respirology. 2019 Dec;24(12):1204-1211. doi: 10.1111/resp.13546. Epub 2019 Apr 22. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | iVAPS With Manual EPAP | This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients. |
|
|
|
| Secondary | Sleep Efficiency (%) | To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time) | Posted | Mean | Standard Deviation | percentage of total sleep time | Overnight, up to 8 hrs on nights 1 and 2 |
|
|
|
| Secondary | Apnea Hypopnea Index (AHI) | To assess sleep-breathing parameters between groups using mean AHI (#events/hour) | Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights. | Posted | Mean | Standard Deviation | events per hour | Overnight, up 8 hrs on night 1 and 2 |
|
|
|
| Secondary | Nadir Arterial Oxygen Saturation (SpO2) | To assess Sleep-breathing parameters between groups using mean SpO2 (%) | Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Overnight, up 8 hrs on night 1 and 2 |
|
|
|
| Secondary | Arterial Carbon Dioxide (PCO2) | To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg) | Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights. | Posted | Mean | Standard Deviation | milimeters of mercury | Overnight, up 8 hrs on night 1 and 2 |
|
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|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | iVAPS With Manual EPAP | This is a crossover study. There were 42 patients randomized in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. Adverse Event data were collected for all 42 enrolled patients. | 0 | 42 | 0 | 42 | 1 | 42 |
|
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