Trial Outcomes & Findings for Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders (NCT NCT01626989)

NCT ID: NCT01626989

Last Updated: 2019-04-25

Results Overview

Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline, and 2 nights (1 night for each intervention)
• Results posted on: 2019-04-25

Participant Flow

Participant milestones

Measure	Screening Population All patients that signed consent are considered for the screening population.	BiPAP Auto SV Advanced First, Then BiPAP Auto SV 4 Participants received the Philips BiPAP Auto SV Advanced for one night, then received the BiPAP Auto SV 4 for one night.	BiPAP Auto SV 4 First, Then BiPAP Auto SV Advanced Participants received the Philips BiPAP Auto SV 4 for one night, then received the BiPAP Auto SV Advanced for one night
Screening Period STARTED	44	0	0
Screening Period COMPLETED	27	0	0
Screening Period NOT COMPLETED	17	0	0
Fist Intervention (Night 1) STARTED	0	15	12
Fist Intervention (Night 1) COMPLETED	0	15	12
Fist Intervention (Night 1) NOT COMPLETED	0	0	0
Second Intervention (Night 2) STARTED	0	15	12
Second Intervention (Night 2) COMPLETED	0	15	12
Second Intervention (Night 2) NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Screening Population All patients that signed consent are considered for the screening population.	BiPAP Auto SV Advanced First, Then BiPAP Auto SV 4 Participants received the Philips BiPAP Auto SV Advanced for one night, then received the BiPAP Auto SV 4 for one night.	BiPAP Auto SV 4 First, Then BiPAP Auto SV Advanced Participants received the Philips BiPAP Auto SV 4 for one night, then received the BiPAP Auto SV Advanced for one night
Screening Period Screen Failure	15	0	0
Screening Period Withdrawal by Subject	2	0	0

Baseline Characteristics

Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders

Baseline characteristics by cohort

Measure	All Study Participants n=44 Participants All study participants that signed consent.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	61.71 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	35 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	39 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	44 participants n=5 Participants
Body Mass Index (BMI)	33.3 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Apnea-Hypopnea Index (AHI)	38 events per hour Standard Deviation 31	13 events per hour Standard Deviation 17	12 events per hour Standard Deviation 18

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices Stage 1	22 percent of TST Standard Deviation 14	18 percent of TST Standard Deviation 10	17 percent of TST Standard Deviation 10
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices Stage 2	61 percent of TST Standard Deviation 14	65 percent of TST Standard Deviation 13	65 percent of TST Standard Deviation 12
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices Stage 3	5 percent of TST Standard Deviation 8	4 percent of TST Standard Deviation 6	5 percent of TST Standard Deviation 6
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices REM	11 percent of TST Standard Deviation 9	13 percent of TST Standard Deviation 9	14 percent of TST Standard Deviation 11

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis. 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Central Apnea Index(CAI)	12 events per hour Standard Deviation 15	1 events per hour Standard Deviation 2	1 events per hour Standard Deviation 3

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Obstructive Apnea Index (OAI)	14 events per hour Standard Deviation 10	1 events per hour Standard Deviation 2	2 events per hour Standard Deviation 4

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Mixed Apnea Index (MAI)	4 events per hour Standard Deviation 7	0.3 events per hour Standard Deviation 0.6	0.6 events per hour Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

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

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Sleep Onset Latency (SOL)	16.6 minutes Standard Deviation 16.3	19.3 minutes Standard Deviation 10.1	24.3 minutes Standard Deviation 20

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: REM onset latency is not a standard set of sleep scores analyzed. This is not apart of the analysis, this is in the protocol by error. However the protocol was not amended.

REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Wake After Sleep Onset (WASO)	59.1 minutes Standard Deviation 48	64.1 minutes Standard Deviation 57.6	54.2 minutes Standard Deviation 29.3

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Total Sleep Time (TST)	354.0 minutes Standard Deviation 74.3	352.4 minutes Standard Deviation 69.2	368.1 minutes Standard Deviation 64.6

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Sleep Efficiency (SE %)	82 percent of time asleep Standard Deviation 13	81 percent of time asleep Standard Deviation 12	82 percent of time asleep Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: Data was not analyzed as number of minutes, as minutes is not a meaningful measurement. It is best measured respective to % TST in outcome measure 2. This was included in the protocol in error and the protocol was not amended.

Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from "lights out," or bedtime, to the onset of sleep.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Arousal Index is 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.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Arousal Index	22 events per hour Standard Deviation 12	16 events per hour Standard Deviation 7	16 events per hour Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Nocturnal Oxygenation	82 percent oxygen saturation Standard Deviation 7	86 percent oxygen saturation Standard Deviation 4	84 percent oxygen saturation Standard Deviation 5

SECONDARY outcome

Timeframe: Baseline, and 2 nights (1 night for each intervention)

Population: 8 participants had missing or unscorable data, therefore they are not included in the analysis.

Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.

Outcome measures

Measure	Continous Positive Airway Pressure Titriation n=19 Participants Baseline Polysomnograph (PSG) to qualify for randomization.	BiPAP Auto SV Advanced n=19 Participants BiPAP auto SV Advanced BiPAP auto Advanced: Auto Servo Ventilation Device	BiPAP Auto SV 4 n=19 Participants Auto Servo Ventilation Device BiPAP auto SV4: Auto Servo Ventilation Device
Hypopnea Index (HI)	9 events per hour Standard Deviation 9	11 events per hour Standard Deviation 15	8 events per hour Standard Deviation 11

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

BiPAP Auto SV Advanced

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BiPAP Auto SV 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=44 participants at risk All Study participants that were consented to the study.	BiPAP Auto SV Advanced n=27 participants at risk All participants that received the Philips BiPAP Auto SV Advanced.	BiPAP Auto SV 4 n=27 participants at risk All participants that received the Philips BiPAP Auto SV 4.
Cardiac disorders Stents	2.3% 1/44 • Number of events 1 • 3 weeks	0.00% 0/27 • 3 weeks	0.00% 0/27 • 3 weeks

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Powers

Philips

Phone: 412-542-3669

Email: jeremy.powers@philips.com

Results disclosure agreements

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