Trial Outcomes & Findings for The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients (NCT NCT03294629)
NCT ID: NCT03294629
Last Updated: 2018-06-12
Results Overview
Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-06-12
Participant Flow
March 2015 to Mar 2016, at medical clinic.
Participant milestones
| Measure |
CPAP w/SensAwake First, Then CPAP w/o SensAwake
Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period.
|
CPAP w/o SensAwake First, Then CPAP w/SensAwake
Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period.
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
16
|
19
|
|
First Intervention (2 Weeks)
COMPLETED
|
14
|
15
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
2
|
4
|
|
Second Intervention (2 Weeks)
STARTED
|
14
|
15
|
|
Second Intervention (2 Weeks)
COMPLETED
|
12
|
13
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients
Baseline characteristics by cohort
| Measure |
CPAP w/SensAwake First, Then CPAP w/o SensAwake
n=12 Participants
Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period.
|
CPAP w/o SensAwake First, Then CPAP w/SensAwake
n=13 Participants
Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.8 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
32.9 kg/m2
STANDARD_DEVIATION 6.9 • n=7 Participants
|
32.4 kg/m2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Neck Circumference (NC)
|
42.3 cm
STANDARD_DEVIATION 2.1 • n=5 Participants
|
41.0 cm
STANDARD_DEVIATION 2.2 • n=7 Participants
|
41.6 cm
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Apnea-hypopnea index (AHI)
|
55.3 events per hour
STANDARD_DEVIATION 30.8 • n=5 Participants
|
54.0 events per hour
STANDARD_DEVIATION 35.3 • n=7 Participants
|
54.6 events per hour
STANDARD_DEVIATION 32.5 • n=5 Participants
|
|
Sleep efficiency
|
82.0 % (percentage of minutes slept)
STANDARD_DEVIATION 8.9 • n=5 Participants
|
73.0 % (percentage of minutes slept)
STANDARD_DEVIATION 21.3 • n=7 Participants
|
77.1 % (percentage of minutes slept)
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Total sleep time
|
301.0 minutes
STANDARD_DEVIATION 34.2 • n=5 Participants
|
276.2 minutes
STANDARD_DEVIATION 79.2 • n=7 Participants
|
287.6 minutes
STANDARD_DEVIATION 62.8 • n=5 Participants
|
|
Deep sleep - Stage 3
|
6.1 % (percentage of minutes of stage 3)
STANDARD_DEVIATION 10.4 • n=5 Participants
|
4.4 % (percentage of minutes of stage 3)
STANDARD_DEVIATION 5.6 • n=7 Participants
|
5.2 % (percentage of minutes of stage 3)
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Average used time of CPAP
|
187.4 minutes
STANDARD_DEVIATION 104.6 • n=5 Participants
|
227.9 minutes
STANDARD_DEVIATION 104.1 • n=7 Participants
|
208.5 minutes
STANDARD_DEVIATION 104.2 • n=5 Participants
|
|
Compliance of CPAP
|
31.9 %
STANDARD_DEVIATION 31.9 • n=5 Participants
|
46.2 %
STANDARD_DEVIATION 30.6 • n=7 Participants
|
39.3 %
STANDARD_DEVIATION 31.4 • n=5 Participants
|
|
Residual AHI under CPAP Tx
|
2.9 events per hour
STANDARD_DEVIATION 1.3 • n=5 Participants
|
4.4 events per hour
STANDARD_DEVIATION 2.8 • n=7 Participants
|
3.7 events per hour
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI)
|
7.4 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Epworth Sleepiness Scale (ESS)
|
13.3 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Nasal Obstruction Symptom Evaluation (NOSE)
|
13.5 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 8.4 • n=7 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksObjective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Compliance of Auto-CPAP Therapy
|
41.8 percentage of nights
Standard Deviation 35.0
|
39.7 percentage of nights
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: 2 weeksAverage detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Average SA Detections
|
2.1 times/hour
Standard Deviation 0.9
|
0 times/hour
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 2 weeksAverage Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Average Pressures of Auto-CPAP Machine
|
6.9 cmH2O
Standard Deviation 2.7
|
7.3 cmH2O
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 weeks90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
90th Percentile Pressures of Auto-CPAP Machine
|
8.6 cmH2O
Standard Deviation 3.0
|
9.2 cmH2O
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 2 weeksAverage leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Average Leaks of Auto-CPAP Machine
|
41.3 liters per minute
Standard Deviation 20.1
|
44.6 liters per minute
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: 2 weeksAverage leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
90th Percentile Leaks of Auto-CPAP Machine
|
57.6 liters per minute
Standard Deviation 24.7
|
58.9 liters per minute
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: 2 weeksResidual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Residual Apnea-Hypopnea Index (AHI)
|
6.3 events per hour
Standard Deviation 6.7
|
5.0 events per hour
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 2 weeksAverage Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Time Used of Auto-CPAP Machine
|
213.1 minutes
Standard Deviation 99.4
|
206.8 minutes
Standard Deviation 87.6
|
SECONDARY outcome
Timeframe: 2 weeksPercentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Percentage of Day Used of Auto-CPAP Machine
|
87.1 Percentage of days
Standard Deviation 13.8
|
88.1 Percentage of days
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 2 weeksThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
8.0 units on a scale
Standard Deviation 2.6
|
8.0 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 2 weeksThe ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Epworth Sleepiness Score (ESS)
|
11.1 units on a scale
Standard Deviation 6.1
|
12.1 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 2 weeksThe Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.
Outcome measures
| Measure |
SA ON
n=25 Participants
CPAP with SensAwake activation
|
SA OFF
n=25 Participants
CPAP without SensAwake activation
|
|---|---|---|
|
Nasal Obstruction Symptom Evaluation (NOSE)
|
14.6 units on a scale
Standard Deviation 8.1
|
13.3 units on a scale
Standard Deviation 6.7
|
Adverse Events
SA ON
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SA OFF
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
Ning-Hung, Chen
Sleep Center, Taoyuan Chang Gung Memorial Hospital
Phone: +886-3-3281200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place