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The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS).
The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVAPS-AE | Experimental | AVAPS-AE Mode of ventilation |
|
| Respironics OmniLab Advanced BiPAP S mode | Active Comparator | OmniLab Advanced BiPAP S Mode of ventilation |
|
| Respironics OmniLab Advanced CPAP mode | Active Comparator | OmniLab Advanced CPAP Mode of ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVAPS-AE Mode of Therapy | Device | AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) | Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks. | Screening & 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02) | Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks. | Screening & 6 weeks |
| Apnea Hypopnea Index (AHI) |
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Inclusion Criteria:
Age greater than or equal to 18 years of age; less than or equal to 70 years of age
Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy
Daytime pH > 7.35
Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) > 70%
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sairam Parthasarathy, MD | Southern Arizona VA Healthcare | Principal Investigator |
| Babak Mokhlesi, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona School of Medicine | Tucson | Arizona | 85723 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32713421 | Derived | Lastra AC, Masa JF, Mokhlesi B. CPAP titration failure is not equivalent to long-term CPAP treatment failure in patients with obesity hypoventilation syndrome: a case series. J Clin Sleep Med. 2020 Nov 15;16(11):1975-1981. doi: 10.5664/jcsm.8712. | |
| 29734990 | Derived | Bhattacharjee R, Khalyfa A, Khalyfa AA, Mokhlesi B, Kheirandish-Gozal L, Almendros I, Peris E, Malhotra A, Gozal D. Exosomal Cargo Properties, Endothelial Function and Treatment of Obesity Hypoventilation Syndrome: A Proof of Concept Study. J Clin Sleep Med. 2018 May 15;14(5):797-807. doi: 10.5664/jcsm.7110. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Screening Period | All study participants that were screened and signed consent. |
| FG001 | AVAPS-AE | AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes. |
| FG002 | Respironics OmniLab Advanced BiPAP S Mode | Non-Invasive Ventilation (NIV) therapy modality in the OmniLab Advanced BiPAP. |
| FG003 | Respironics OmniLab Advanced CPAP Mode | Non-Invasive Ventilation (NIV) therapy modality in the Respironics OmniLab Advanced CPAP |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
|
| ||||||||||||||||||
| Study Period |
|
All participants that signed the consent form are considered for the baseline demographics
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants that signed the consent are included in the baseline characteristics to due the high screen failure rate and large number of participants that discontinued the study. |
| 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 | Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) | Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks. | 6 participants withdrew from the study and therefore did not provide values at week 6. | Posted | Mean | Standard Deviation | mmHg | Screening & 6 weeks |
|
All Adverse Events experienced over 6 weeks were collected.
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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 | AVAPS-AE | AVAPS-AE Mode of ventilation AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Jasko | Philips | 412-542-3651 | jeff.jasko@philips.com |
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| ID | Term |
|---|---|
| D010845 | Obesity Hypoventilation Syndrome |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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| Respironics OnmiLab BiPAP S mode | Device | Currently cleared Non-Invasive Ventilation (NIV) therapy modality |
|
| Respironics OmniLab Advanced CPAP mode | Device | Currently cleared NIV therapy modality |
|
The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe. |
| Screening & 6 weeks |
| Epworth Sleepiness Scale | Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep. | Screening & 6 weeks |
| Severe Respiratory Insufficiency Questionnaire (SRIQ) | The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale. | Screening & 6 weeks |
| Ventilator Adherence - Average Hours | The average number of hours ventilator was used per each day used. | 6 weeks |
| Ventilator Adherence - Days Used | Average number of days used per week | 6 weeks |
| Actigraphy | Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use. | Screening & 6 weeks |
| Room Air Sp02 Assessment Via Pulse Oximetry | Oxygen saturation measurements as determined by pulse oximetry | Screening & 6 weeks |
| Nocturnal Transcutaneous Capnography (TcC02) | Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. . | Screening & 6 weeks |
| Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration | Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep. | Screening & 6 weeks |
| Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency | Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep. | Screening & 6 weeks |
| Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices | The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep. | Screening & 6 weeks |
| Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation | Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2) | Screening & 6 weeks |
| Reaction Time (Psychomotor Vigilance Test-PVT) | To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms. | Screening & 6 weeks |
| Number of Participants With Need for Continued Oxygen Supplementation | Some users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks. | Screening & 6 weeks |
| Chicago |
| Illinois |
| 60637 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
| OG002 | Respironics OmniLab Advanced CPAP Mode | OmniLab Advanced CPAP Mode of ventilation Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality |
|
|
| Secondary | Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02) | Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks. | 6 participants withdrew from the study and therefore did not provide values at week 6. | Posted | Mean | Standard Deviation | mmHg | Screening & 6 weeks |
|
|
|
| Secondary | Apnea Hypopnea Index (AHI) | The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe. | 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure. | Posted | Mean | Standard Deviation | events per hour | Screening & 6 weeks |
|
|
|
| Secondary | Epworth Sleepiness Scale | Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep. | 6 participants withdrew from the study and therefore did not provide values at week 6. 1 participant did not complete the ESS at the end of the study. | Posted | Mean | Standard Deviation | units on a scale | Screening & 6 weeks |
|
|
|
| Secondary | Severe Respiratory Insufficiency Questionnaire (SRIQ) | The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale. | 6 participants withdrew from the study and therefore did not provide values at week 6. | Posted | Mean | Standard Deviation | units on a scale | Screening & 6 weeks |
|
|
|
| Secondary | Ventilator Adherence - Average Hours | The average number of hours ventilator was used per each day used. | 6 participants withdrew from the study and therefore did not provide values at week 6. | Posted | Mean | Standard Deviation | Hours per day | 6 weeks |
|
|
|
| Secondary | Ventilator Adherence - Days Used | Average number of days used per week | 6 participants withdrew from the study and therefore did not provide values at week 6. | Posted | Mean | Standard Deviation | days per week | 6 weeks |
|
|
|
| Secondary | Actigraphy | Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use. | Participants were asked to wear an actiwatch to measure actigraphy. Actigraphy was reviewed as part of the study however a detailed analysis was not conducted because the data was to variable. | Posted | Screening & 6 weeks |
|
|
| Secondary | Room Air Sp02 Assessment Via Pulse Oximetry | Oxygen saturation measurements as determined by pulse oximetry | 6 participants withdrew from the study and therefore did not provide values at week 6. | Posted | Mean | Standard Deviation | percentage of oxygen saturation (SpO2) | Screening & 6 weeks |
|
|
|
| Secondary | Nocturnal Transcutaneous Capnography (TcC02) | Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. . | This measure was not a standard practice of the sleep scoring company and was not done. | Posted | Screening & 6 weeks |
|
|
| Secondary | Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration | Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep. | 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure. | Posted | Mean | Standard Deviation | percentage of time spent in that stage | Screening & 6 weeks |
|
|
|
| Secondary | Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency | Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep. | 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure. | Posted | Mean | Standard Deviation | percentage of time spent in that stage | Screening & 6 weeks |
|
|
|
| Secondary | Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices | The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep. | 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure. | Posted | Mean | Standard Deviation | arousals per hour | Screening & 6 weeks |
|
|
|
| Secondary | Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation | Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2) | 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure. | Posted | Mean | Standard Deviation | percentage of oxygen saturation (SpO2) | Screening & 6 weeks |
|
|
|
| Secondary | Reaction Time (Psychomotor Vigilance Test-PVT) | To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms. |
| Posted | Median | Standard Deviation | milliseconds | Screening & 6 weeks |
|
|
|
| Secondary | Number of Participants With Need for Continued Oxygen Supplementation | Some users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks. | Posted | Count of Participants | Participants | Screening & 6 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Respironics OmniLab Advanced BiPAP S Mode | OmniLab Advanced BiPAP S Mode of ventilation Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Respironics OmniLab Advanced CPAP Mode | OmniLab Advanced CPAP Mode of ventilation Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality | 0 | 11 | 2 | 11 | 1 | 11 |
| Fournier's Gangrene | Renal and urinary disorders | Non-systematic Assessment |
|
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Not provided
| D012140 |
| Respiratory Tract Diseases |
| D007040 | Hypoventilation |
| D012131 | Respiratory Insufficiency |
| 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 |
| Week 6 |
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| Titration |
|
|
| Week 6 |
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| Week 6 |
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| Week 6 |
|
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| Week 6 |
|
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| Total Sleep Time Stage 1- 6 weeks |
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| Total Sleep Time Stage 2- Screening |
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| Total Sleep Time Stage 2-6 weeks |
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| Total Sleep Time Stage 3/4 - Screening |
|
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| Total Sleep Time Stagev3/4-6 weeks |
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| Total Sleep Time Stage REM- Screening |
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| Total Sleep Time Stage REM-6 weeks |
|
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| Sleep Efficiency - 6 weeks |
|
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| 6 weeks |
|
|
| 6 weeks |
|
|
| 6 weeks |
|
|
| Title | Measurements |
|---|---|
|
| At Sleep- Screening |
|
| At Sleep- 6 weeks |
|
| At Exertion- Screening |
|
| At Exertion- 6 weeks |
|