Trial Outcomes & Findings for Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment. (NCT NCT00906958)
NCT ID: NCT00906958
Last Updated: 2021-03-22
Results Overview
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
COMPLETED
NA
20 participants
One Night On Each Arm, approximately 8 hours each night
2021-03-22
Participant Flow
Participant milestones
| Measure |
Modified Autoset (Nexus Flow Generator)
AutoSet algorithms measure breathing patterns and respond to increase or decresase pressures to overcome obstructive sleep apnea. The modified AutoSet algorithm contains software updates to better measure and respond to sleep apnea. Participants used this device for one night, followed by the standard AutoSet, in a randomised order
|
VPAP Flow Generator 25
Existing AutoSet algorithm for the treatment of obstructive sleep apnea. Participants used this device for one night, followed by the modified AutoSet algorithm, in a randomised order
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
This was a cross-over study, therefore all participants were assigned to both interventions, for one night each, in a randomised order
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One Night On Each Arm, approximately 8 hours each nightPopulation: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
Outcome measures
| Measure |
Nexus Flow Generator
n=20 Participants
Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.
|
VPAP Flow Generator 25
n=20 Participants
Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.
|
|---|---|---|
|
Apnoea-Hypopnoea Index (AHI)
|
1.69 Events/Hour
Standard Deviation 2.37
|
1.73 Events/Hour
Standard Deviation 1.58
|
PRIMARY outcome
Timeframe: One Night On Each Arm, approximately 8 hours each nightPopulation: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.
Number of oxygen desaturations per hour of sleep
Outcome measures
| Measure |
Nexus Flow Generator
n=20 Participants
Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.
|
VPAP Flow Generator 25
n=20 Participants
Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.
|
|---|---|---|
|
Oxygen Desaturation Index
|
1.95 Events/Hour
Standard Deviation 2.33
|
1.68 Events/Hour
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: One Night On Each Arm, approximately 8 hours each nightPopulation: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.
Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale
Outcome measures
| Measure |
Nexus Flow Generator
n=20 Participants
Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.
|
VPAP Flow Generator 25
n=20 Participants
Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.
|
|---|---|---|
|
Comfort of Breathing
|
8.0 Scores on a Scale
Interval 5.0 to 10.0
|
7.0 Scores on a Scale
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: One Night On Each Arm, approximately 8 hours each nightPopulation: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.
Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale
Outcome measures
| Measure |
Nexus Flow Generator
n=20 Participants
Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.
|
VPAP Flow Generator 25
n=20 Participants
Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.
|
|---|---|---|
|
Satisfaction of Treatment
|
9.5 Scores on a scale
Interval 5.0 to 10.0
|
8.0 Scores on a scale
Interval 3.0 to 10.0
|
SECONDARY outcome
Timeframe: One Night On Each Arm, approximately 8 hours each nightPopulation: Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.
Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?
Outcome measures
| Measure |
Nexus Flow Generator
n=20 Participants
Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.
|
VPAP Flow Generator 25
n=20 Participants
Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.
|
|---|---|---|
|
Refreshed Feel
|
9.0 Scores on a scale
Interval 6.0 to 10.0
|
8.0 Scores on a scale
Interval 5.0 to 10.0
|
Adverse Events
Nexus Flow Generator
VPAP Flow Generator 25
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place