Trial Outcomes & Findings for CPAP vs ASV for Insomnia (NCT NCT02365064)
NCT ID: NCT02365064
Last Updated: 2021-09-09
Results Overview
Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Baseline and 4 months
Results posted on
2021-09-09
Participant Flow
Participant milestones
| Measure |
Continuous Positive Airway Pressure
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
47
|
|
Overall Study
Included in ITT Analysis
|
29
|
32
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
10
|
28
|
Reasons for withdrawal
| Measure |
Continuous Positive Airway Pressure
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Overall Study
Patients met baseline exclusion requirem
|
2
|
15
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
Treatment intolerance
|
2
|
4
|
Baseline Characteristics
CPAP vs ASV for Insomnia
Baseline characteristics by cohort
| Measure |
Continuous Positive Airway Pressure
n=29 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=32 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.95 years
n=5 Participants
|
45.89 years
n=7 Participants
|
45.44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsChange in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia.
Outcome measures
| Measure |
Continuous Positive Airway Pressure
n=21 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=19 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Insomnia Severity Index
|
9.29 units on a scale
Standard Deviation 6.57
|
13.21 units on a scale
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: Baseline and 4 months8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality
Outcome measures
| Measure |
Continuous Positive Airway Pressure
n=21 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=19 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Sleep Quality Rating
|
1.06 score on a scale
Standard Deviation 1.00
|
1.65 score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 4 monthsChange in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience
Outcome measures
| Measure |
Continuous Positive Airway Pressure
n=21 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=19 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Global Morning Rating
|
15.39 units on a scale
Standard Deviation 20.03
|
24.33 units on a scale
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: 4 monthsChange in from baseline to 4 months in sleep onset time (minutes)
Outcome measures
| Measure |
Continuous Positive Airway Pressure
n=21 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=19 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Sleep Onset Latency
|
-6.09 minutes
Standard Deviation 44.39
|
7.17 minutes
Standard Deviation 26.90
|
SECONDARY outcome
Timeframe: 4 monthsChange from baseline to 4 months for WASO in minutes
Outcome measures
| Measure |
Continuous Positive Airway Pressure
n=21 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=19 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Wake After Sleep Onset (WASO)
|
5.72 minutes
Standard Deviation 58.73
|
-0.12 minutes
Standard Deviation 61.88
|
SECONDARY outcome
Timeframe: 4 monthsChange from baseline to 4 months in sleep efficiency (total sleep time/time in bed)
Outcome measures
| Measure |
Continuous Positive Airway Pressure
n=21 Participants
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
Adaptive Servo-Ventilation
n=19 Participants
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
AirCurve 10 ASV: Device is able to provide both ASV therapy and CPAP therapy modes.
|
|---|---|---|
|
Sleep Efficiency
|
0.75 percentage of time in bed
Standard Deviation 16.68
|
-2.85 percentage of time in bed
Standard Deviation 16.05
|
Adverse Events
Continuous Positive Airway Pressure
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Adaptive Servo-Ventilation
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Positive Airway Pressure
n=21 participants at risk
Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
|
Adaptive Servo-Ventilation
n=19 participants at risk
Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
mask leak
|
95.2%
20/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
84.2%
16/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
dry mouth
|
90.5%
19/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
84.2%
16/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
71.4%
15/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
68.4%
13/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
mask related insomnia
|
61.9%
13/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
57.9%
11/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
mouth leak
|
57.1%
12/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
57.9%
11/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
52.4%
11/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
63.2%
12/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Skin and subcutaneous tissue disorders
skin crease from mask
|
57.1%
12/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
47.4%
9/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
nose tickle/ burn
|
52.4%
11/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
47.4%
9/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
aerophagia
|
42.9%
9/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
36.8%
7/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
|
Respiratory, thoracic and mediastinal disorders
eye irritation
|
33.3%
7/21 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
42.1%
8/19 • 4 months
Participants were asked to report side effects commonly related to CPAP usage, including: Drying of the nose, mouth or throat, Nosebleed, Ear or sinus discomfort, Eye irritation, Skin rashes Participants may report multiple side effects
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place