Trial Outcomes & Findings for Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device (NCT NCT00720213)

Results Overview

The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

2 nights

Results posted on

2019-01-29

Participant Flow

Participants were recruited from the investigators' sleep labs.

Participants were excluded if they did not demonstrate an Apnea-Hypopnea Index (AHI) ≥ 10 and Central Apnea Index (CAI)≥ 5 during the diagnostic polysomnography (PSG), or if they did not demonstrate a CAI ≥ 5 on continuous positive airway pressure (CPAP) titration.

Participant milestones

Participant milestones
Measure	Screening Phase All participants that signed a consent form.	BiPap Auto SV2 Device First, BiPap Auto SV3 Device Second BiPAP auto servo ventilation (SV) 2 Device. This arm used the BiPAP AutoSV2 overnight first overnight, followed by the BiPAP auto servo ventilation (SV) 3 Device. This arm used the BiPAP AutoSV3 for the second overnight.	BiPap Auto SV3 Device First, BiPap AutoSV2 Device Second BiPAP auto servo ventilation (SV) 3 Device. This arm used the BiPAP AutoSV3 for the first overnight. The second overnight participants used the BiPap Auto Servo Ventilation 2 Device.
Screening Phase With Diagnostic PSG STARTED	44	0	0
Screening Phase With Diagnostic PSG COMPLETED	37	0	0
Screening Phase With Diagnostic PSG NOT COMPLETED	7	0	0
Treatment Period STARTED	0	20	17
Treatment Period COMPLETED	0	20	17
Treatment Period NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Screening Phase All participants that signed a consent form.	BiPap Auto SV2 Device First, BiPap Auto SV3 Device Second BiPAP auto servo ventilation (SV) 2 Device. This arm used the BiPAP AutoSV2 overnight first overnight, followed by the BiPAP auto servo ventilation (SV) 3 Device. This arm used the BiPAP AutoSV3 for the second overnight.	BiPap Auto SV3 Device First, BiPap AutoSV2 Device Second BiPAP auto servo ventilation (SV) 3 Device. This arm used the BiPAP AutoSV3 for the first overnight. The second overnight participants used the BiPap Auto Servo Ventilation 2 Device.
Screening Phase With Diagnostic PSG Screen Failure	7	0	0

Baseline Characteristics

Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=37 Participants Participants who signed the informed consent
Age, Continuous	53.2 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants
Body Mass Index	31 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: 2 nights

The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Apnea Hypopnea Index	10.44 events/hour Standard Deviation 10.3	6.06 events/hour Standard Deviation 5.81

SECONDARY outcome

Timeframe: 2 nights

Population: Data was not scorable for NREM.

The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement) A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Apnea Hypopnea Index- REM and NREM Apnea Hypopnea Index- REM	3.27 events/hour Standard Deviation 6.15	2.09 events/hour Standard Deviation 3.74
Apnea Hypopnea Index- REM and NREM Apnea Hypopnea Index- NREM	6.84 events/hour Standard Deviation 6.52	11.74 events/hour Standard Deviation 11.70

SECONDARY outcome

Timeframe: 2 nights

The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort. A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Central Apnea Index	2.82 events/hour Standard Deviation 3.72	0.56 events/hour Standard Deviation .71

SECONDARY outcome

Timeframe: 2 nights

Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway. A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Obstructive Apnea Index	2.04 events/hour Standard Deviation 2.35	1.14 events/hour Standard Deviation 1.59

SECONDARY outcome

Timeframe: 2 nights

Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Mixed Apnea Index	0.44 events/hour Standard Deviation .69	0.20 events/hour Standard Deviation 0.37

SECONDARY outcome

Timeframe: 2 nights

Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Hypopnea Index	5.11 events/hour Standard Deviation 6.22	4.16 events/hour Standard Deviation 4.97

SECONDARY outcome

Timeframe: 2 nights

Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Sleep Onset Latency	18.91 minutes Standard Deviation 18.53	20.91 minutes Standard Deviation 16.76

SECONDARY outcome

Timeframe: 2 nights

Timeframe: 2 nights

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) Stage 1	16.72 minutes Standard Deviation 11.79	16.02 minutes Standard Deviation 9.19
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) Stage 2	54.54 minutes Standard Deviation 11.62	55.06 minutes Standard Deviation 11.99
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) Stage 3 & 4	13.25 minutes Standard Deviation 9.81	11.75 minutes Standard Deviation 10.29
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) REM	15.50 minutes Standard Deviation 6.35	17.18 minutes Standard Deviation 7.43

SECONDARY outcome

Timeframe: 2 nights

The number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']	26.04 events per hour Standard Deviation 11.11	23.58 events per hour Standard Deviation 10.59

SECONDARY outcome

Timeframe: 2 nights

Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.

Outcome measures

Outcome measures
Measure	Respironics BiPAP autoSV2 n=37 Participants Respironics BiPAP autoSV2	Respironics BiPAP autoSV3 n=37 Participants Respironics BiPAP autoSV3
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) Baseline Nocturnal oxygenation (%)	95.78 percentage of oxygen saturation Standard Deviation 1.18	95.7 percentage of oxygen saturation Standard Deviation 1.43
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) Lowest Nocturnal oxygenation (%)	86.54 percentage of oxygen saturation Standard Deviation 8.74	87.84 percentage of oxygen saturation Standard Deviation 4.60

SECONDARY outcome

Timeframe: 2 nights

Population: During scoring of the PSG the modified hypopnea rule wasn't utlized therefore this data is not provided.

This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 nights

Population: This was not part of the standard scoring of the PSG, therefore this was not calculated

The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group 2

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

Shahrokh Javaheri, MD

Sleepcare Diagnostics

Phone: 513-459-7750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60