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Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiPAP autoSV Advanced Device | Other | Positive airway pressure device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP autoSV Advanced | Device | The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea/Hypopnea Index (AHI) | To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights. | During a single night of polysomnography lasting up to 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale | To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24. Interpretation: Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention. Score 16-24: Excessive sleepiness and patient should consider seeking medical attention A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness. |
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Inclusion Criteria:
Males and females, ages 21-75.
Able and willing to provide written informed consent.
Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.
Systolic blood pressure > 80 mm Hg at Visit 1.
Agreement to undergo a full-night, attended Diagnostic PSG.
Agreement to undergo a full-night, attended CPAP titration PSG.
Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahrokh Javaheri, MD | Sleepcare Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaylord Hospital - Gaylord Sleep Research | Wallingford | Connecticut | 06492 | United States | ||
| Kentucky Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25950507 | Derived | Javaheri S, Winslow D, McCullough P, Wylie P, Kryger MH. The Use of a Fully Automated Automatic Adaptive Servoventilation Algorithm in the Acute and Long-term Treatment of Central Sleep Apnea. Chest. 2015 Dec;148(6):1454-1461. doi: 10.1378/chest.14-2966. |
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Twenty-nine patients were enrolled between September 2010 and February 2013. Two participants did not meet) criteria after centralized scoring of diagnostic and CPAP polysomnograms (PSGs) and were excluded from analysis. Twenty-seven participants (five women) completed 3 nights in-laboratory attended PSG, and 26 completed 3 months of follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV | All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sleep Laboratory (3 Nights) |
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| ||||||||||||||||||
| At Home (3 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic, Then CPAP, Then BiPAP autoSV Advanced | Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design) |
| 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 | Apnea/Hypopnea Index (AHI) | To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights. | Posted | Mean | Standard Deviation | Apnea-Hypopnea events per hour | During a single night of polysomnography lasting up to 8 hours. |
|
Duration of study: 2 years and 5 months
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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 | Diagnostic, Then CPAP, Then BiPAP autoSV Advanced | Participants had a diagnostic PSG, then CPAP and BiPAP autoSV. Participants then went home and used the autoSV for 90 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shahrokh Javaheri | Bethesda North Hospital | 513-793-7378 | shahrokhjavaheri@icloud.com |
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| ID | Term |
|---|---|
| D002639 | Cheyne-Stokes Respiration |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| 3 months |
| Breathing Event Indexes | To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy. Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment. | from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment |
| Average Therapy Pressure Values | To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time. This analysis compares the average pressure support of the first week compared to the average pressure support to the final week. | 3 months |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Sleepcare Diagnostics | Mason | Ohio | 45040 | United States |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index |
|
|
| Secondary | Epworth Sleepiness Scale | To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24. Interpretation: Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention. Score 16-24: Excessive sleepiness and patient should consider seeking medical attention A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness. | 26 participants completed the 3-month home follow-up. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Breathing Event Indexes | To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy. Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment. | 26 participants completed the 3-month home follow-up. | Posted | Mean | Standard Deviation | Apnea-Hypopnea events per hour | from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment |
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|
|
| Secondary | Average Therapy Pressure Values | To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time. This analysis compares the average pressure support of the first week compared to the average pressure support to the final week. | 26 participants completed the 3-month home follow-up. | Posted | Mean | Standard Deviation | cm/H2O | 3 months |
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| 0 |
| 27 |
| 0 |
| 27 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |