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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
Gaylord Hospital - Gaylord Sleep Research
Wallingford, Connecticut, United States
Kentucky Research Group
Louisville, Kentucky, United States
Sleepcare Diagnostics
Mason, Ohio, United States
Apnea/Hypopnea Index (AHI)
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
Time frame: During a single night of polysomnography lasting up to 8 hours.
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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