Trial Outcomes & Findings for Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients (NCT NCT01199042)

Results Overview

To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

During a single night of polysomnography lasting up to 8 hours.

Results posted on

2016-04-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Sleep Laboratory (3 Nights) STARTED	29
Sleep Laboratory (3 Nights) COMPLETED	27
Sleep Laboratory (3 Nights) NOT COMPLETED	2
At Home (3 Months) STARTED	27
At Home (3 Months) COMPLETED	26
At Home (3 Months) NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Sleep Laboratory (3 Nights) Didn't meet inclusion/exclusion criteria	2
At Home (3 Months) Lost to Follow-up	1

Baseline Characteristics

Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic, Then CPAP, Then BiPAP autoSV Advanced n=27 Participants Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)
Age, Continuous	59 years STANDARD_DEVIATION 12 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	22 Participants n=93 Participants
Race/Ethnicity, Customized African American	1 participants n=93 Participants
Race/Ethnicity, Customized Caucasian	25 participants n=93 Participants
Race/Ethnicity, Customized African American, Irish, Native American	1 participants n=93 Participants
Region of Enrollment United States	27 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diagnostic Apnea-Hypopnea Index n=27 Participants Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured	Continuous Positive Airway Pressure Apnea-Hypopnea Index n=27 Participants The CPAP machine was used to determine the Apnea-Hypopnea Index.	BiPAP autoSV Apnea-Hypopnea Index n=27 Participants The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
Apnea/Hypopnea Index (AHI)	55 Apnea-Hypopnea events per hour Standard Deviation 24	37 Apnea-Hypopnea events per hour Standard Deviation 22	12 Apnea-Hypopnea events per hour Standard Deviation 20

SECONDARY outcome

Timeframe: 3 months

Population: 26 participants completed the 3-month home follow-up.

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.

Outcome measures

Outcome measures
Measure	Diagnostic Apnea-Hypopnea Index n=26 Participants Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured	Continuous Positive Airway Pressure Apnea-Hypopnea Index The CPAP machine was used to determine the Apnea-Hypopnea Index.	BiPAP autoSV Apnea-Hypopnea Index The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
Epworth Sleepiness Scale Baseline (visit 1)	12.8 units on a scale Standard Deviation 5	—	—
Epworth Sleepiness Scale 3 months (visit 6)	7.8 units on a scale Standard Deviation 4	—	—

SECONDARY outcome

Timeframe: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment

Population: 26 participants completed the 3-month home follow-up.

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.

Outcome measures

Outcome measures
Measure	Diagnostic Apnea-Hypopnea Index n=26 Participants Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured	Continuous Positive Airway Pressure Apnea-Hypopnea Index The CPAP machine was used to determine the Apnea-Hypopnea Index.	BiPAP autoSV Apnea-Hypopnea Index The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
Breathing Event Indexes First Week	11.6 Apnea-Hypopnea events per hour Standard Deviation 8.7	—	—
Breathing Event Indexes Last Week	10.0 Apnea-Hypopnea events per hour Standard Deviation 6.8	—	—

SECONDARY outcome

Timeframe: 3 months

Population: 26 participants completed the 3-month home follow-up.

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.

Outcome measures

Outcome measures
Measure	Diagnostic Apnea-Hypopnea Index n=26 Participants Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured	Continuous Positive Airway Pressure Apnea-Hypopnea Index The CPAP machine was used to determine the Apnea-Hypopnea Index.	BiPAP autoSV Apnea-Hypopnea Index The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
Average Therapy Pressure Values First Week	3.7 cm/H2O Standard Deviation 2.0	—	—
Average Therapy Pressure Values Last Week	3.9 cm/H2O Standard Deviation 1.7	—	—

Adverse Events

Diagnostic, Then CPAP, Then BiPAP autoSV Advanced

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shahrokh Javaheri

Bethesda North Hospital

Phone: 513-793-7378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place