Trial Outcomes & Findings for Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device (NCT NCT01241604)

NCT ID: NCT01241604

Last Updated: 2019-04-09

Results Overview

The number of apneas and hypopneas per hour of sleep.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 2 nights
• Results posted on: 2019-04-09

Participant Flow

Patients were recruited from one site to evaluate software enhancements. The study enrolled patients in the spring of 2009.

Participant milestones

Measure	Screening Population All participants that signed consent are considered for the screening population.	Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3 Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device	Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T Auto Servo Ventilation Device and then Mechanical Non-invasive Ventilation
Screening Period STARTED	11	0	0
Screening Period COMPLETED	8	0	0
Screening Period NOT COMPLETED	3	0	0
Study Period STARTED	0	5	3
Study Period COMPLETED	0	5	3
Study Period NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Screening Population All participants that signed consent are considered for the screening population.	Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3 Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device	Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T Auto Servo Ventilation Device and then Mechanical Non-invasive Ventilation
Screening Period Screen Failure	3	0	0

Baseline Characteristics

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

Baseline characteristics by cohort

Measure	All Participants n=8 Participants All participants that were consented.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
BMI	28.8 kg/m^2 STANDARD_DEVIATION 3.8 • n=5 Participants

PRIMARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The number of apneas and hypopneas per hour of sleep.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Apnea Hypopnea Index	19.24 events per hour Standard Deviation 16.72	15.85 events per hour Standard Deviation 17.24

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Apnea Hypopnea Index- REM	10.16 events per hour Standard Deviation 5.14	4.21 events per hour Standard Deviation 4.49

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The central apnea index is the number of central apneas divided by the number of hours of sleep.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Central Apnea Index	0.14 events per hour Standard Deviation 0.25	0.11 events per hour Standard Deviation 0.14

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The obstructive apnea index is the number of obstructive apneas per hour of sleep.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Obstructive Apnea Index	0 events per hour Standard Deviation 0	0 events per hour Standard Deviation 0

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Mixed Apnea Index	0 events per hour Standard Deviation 0	0 events per hour Standard Deviation 0

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The hypopnea index is number hypopneas per hour.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Hypopnea Index	19.1 events per hour Standard Deviation 16.54	15.74 events per hour Standard Deviation 17.23

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Sleep Onset Latency	43.25 minutes Standard Deviation 41.98	64.58 minutes Standard Deviation 81.64

SECONDARY outcome

Timeframe: 2 nights

Population: This analysis was not done because this is not a standard measurement.

REM Onset Latency is the time it takes to fall into REM sleep.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Wake After Sleep Onset	72.58 minutes Standard Deviation 63.25	67.67 minutes Standard Deviation 39.86

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Total Sleep time is total amount of time a participant is asleep from lights off to lights on.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Total Sleep Time	331.83 minutes Standard Deviation 66.7	352.67 minutes Standard Deviation 63.5

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Sleep Efficiency is the percentage of time spent asleep while in bed.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Sleep Efficiency	74.78 percentage of time asleep Standard Deviation 12.36	73.42 percentage of time asleep Standard Deviation 16.96

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The periodic limb movement is the number of periodic limb movements per hour of sleep.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Periodic Limb Movement Index	7.32 movements per hour Standard Deviation 10.4	4 movements per hour Standard Deviation 5.90

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The arousal index is the number of arousals or awakenings per hour of sleep.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Arousal Index	27.33 arousals per hour Standard Deviation 14.3	23.76 arousals per hour Standard Deviation 15.11

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Stages N1,N2,N3 and REM (R) Sleep (% TST) Stage N2	82.48 percentage of TST per night Standard Deviation 15.54	83.44 percentage of TST per night Standard Deviation 9.01
Stages N1,N2,N3 and REM (R) Sleep (% TST) Stage N3	4.1 percentage of TST per night Standard Deviation 8.14	4.27 percentage of TST per night Standard Deviation 8.06
Stages N1,N2,N3 and REM (R) Sleep (% TST) REM	11.26 percentage of TST per night Standard Deviation 8.13	10.92 percentage of TST per night Standard Deviation 4.8
Stages N1,N2,N3 and REM (R) Sleep (% TST) Stage N1	2.16 percentage of TST per night Standard Deviation 2.95	1.37 percentage of TST per night Standard Deviation 0.82

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

The average amount of time spent N1, N2, N3 and REM in minutes per night.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Stages N1,N2,N3 and REM (R) Sleep (in Minutes) Stage N1	7.17 minutes Standard Deviation 10.46	4.83 minutes Standard Deviation 3.33
Stages N1,N2,N3 and REM (R) Sleep (in Minutes) Stage N2	271.33 minutes Standard Deviation 70.03	294.92 minutes Standard Deviation 67.18
Stages N1,N2,N3 and REM (R) Sleep (in Minutes) Stage N3	15.25 minutes Standard Deviation 28.02	17.25 minutes Standard Deviation 23.01
Stages N1,N2,N3 and REM (R) Sleep (in Minutes) REM	37.92 minutes Standard Deviation 32.74	37.67 minutes Standard Deviation 17.44

SECONDARY outcome

Timeframe: 2 nights

Population: One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable. One subject had no pain related medical history and therefore was excluded from analysis.

Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.

Outcome measures

Measure	Respironics BiPAP S/T n=6 Participants Control Arm using Respironics BiPAP S/T BiPAP S/T: Mechanical Non-invasive Ventilation	Respironics BiPAP Auto SV3 n=6 Participants Treatment arm using Respironics BiPAP Auto SV3 BiPAP Auto SV3: Auto Servo Ventilation Device
Nocturnal Oxygenation Index	24 oxygen saturation index Standard Deviation 24.9	19.93 oxygen saturation index Standard Deviation 19.97

SECONDARY outcome

Timeframe: 2 nights

Population: The Apnea Hyopnea Index(AHI) was analyzed and results were provided. The AHI using the modified hypopnea rule was not conducted. This is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.

The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 nights

Population: The Apnea Hypopnea Index (AHI) was analyzed and results were provided. However the epochs were not separated out as this is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.

The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.

Outcome measures

Outcome data not reported

Adverse Events

Screening Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T

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

Jeremy Powers

Philips Respironics

Phone: 412-542-3669

Email: jeremy.powers@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place