Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
|ClinicalTrials.gov Identifier: NCT01199042|
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : April 28, 2016
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cheyne-Stokes Respiration Sleep Apnea, Central||Device: BiPAP autoSV Advanced||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
BiPAP autoSV Advanced Device
Positive airway pressure device
Device: BiPAP autoSV Advanced
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
- Apnea/Hypopnea Index (AHI) [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ]To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
- Epworth Sleepiness Scale [ Time Frame: 3 months ]
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.
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.
- Breathing Event Indexes [ Time Frame: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment ]
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.
- Average Therapy Pressure Values [ Time Frame: 3 months ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199042
|United States, Connecticut|
|Gaylord Hospital - Gaylord Sleep Research|
|Wallingford, Connecticut, United States, 06492|
|United States, Kentucky|
|Kentucky Research Group|
|Louisville, Kentucky, United States, 40217|
|United States, Ohio|
|Mason, Ohio, United States, 45040|
|Principal Investigator:||Shahrokh Javaheri, MD||Sleepcare Diagnostics|