Trial Outcomes & Findings for AutoSet for Her Clinical Trial Protocol (NCT NCT01826513)
NCT ID: NCT01826513
Last Updated: 2017-03-27
Results Overview
Number of apnoeas and hypopnoeas per hour of sleep
COMPLETED
NA
25 participants
1 day
2017-03-27
Participant Flow
Participant milestones
| Measure |
Unblinded Investigational Arm
Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
|
Standard AutoSet Algorithm
Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
|
Modified AutoSet Then Standard AutoSet
Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
|
|---|---|---|---|
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Overall Study
STARTED
|
5
|
10
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AutoSet for Her Clinical Trial Protocol
Baseline characteristics by cohort
| Measure |
Unblinded Investigational Arm
n=5 Participants
Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
|
Standard AutoSet Algorithm
n=10 Participants
Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
|
Modified AutoSet Then Standard AutoSet
n=10 Participants
Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Age, Continuous
|
43.60 years
STANDARD_DEVIATION 7.70 • n=99 Participants
|
44.10 years
STANDARD_DEVIATION 3.78 • n=107 Participants
|
45.60 years
STANDARD_DEVIATION 6.13 • n=206 Participants
|
44.85 years
STANDARD_DEVIATION 5.02 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
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10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
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Region of Enrollment
Australia
|
5 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
25 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Number of apnoeas and hypopnoeas per hour of sleep
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Apnoea Hypopnoea Index (AHI)
|
0.96 events/hour
Standard Deviation 1.40
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0.91 events/hour
Standard Deviation 0.90
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PRIMARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Number of oxygen desaturations per hour of sleep
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
|
Oxygen Desaturation Index (ODI)
|
1.92 events/hour
Standard Deviation 1.82
|
2.19 events/hour
Standard Deviation 2.15
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Sleep time divided by total time available for sleep
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Sleep Efficacy
|
85.99 percentage of total recorded time
Standard Deviation 8.55
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84.14 percentage of total recorded time
Standard Deviation 9.62
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Time awake in minutes after initial sleep onset
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Wake After Sleep Onset Time
|
47.52 minutes
Standard Deviation 34.57
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57.42 minutes
Standard Deviation 43.31
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Time in minutes taken to fall alseep
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Time Taken to Fall Asleep
|
16.52 minutes
Standard Deviation 19.58
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16.25 minutes
Standard Deviation 12.70
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Number of spontaneous arousals occurring over the entire total sleep time
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Number of Spontaneous Arousals
|
85.55 Spontaneous Arousals
Standard Deviation 40.88
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81.40 Spontaneous Arousals
Standard Deviation 33.91
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Total number of hypopnoeas occurring in the total sleep time
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Number of Hypopnoeas
|
1.45 Hypopneas
Standard Deviation 2.33
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2.00 Hypopneas
Standard Deviation 3.42
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Total number of obstructive apnoeas occurring in the total sleep time
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Number of Obstructive Apnoeas
|
1.30 Obstructive Apnoeas
Standard Deviation 4.44
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0.80 Obstructive Apnoeas
Standard Deviation 1.36
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SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Total number of central apnoeas occurring in the total sleep time
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
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Number of Central Apnoeas
|
3.55 Central Apnoeas
Standard Deviation 7.45
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3.00 Central Apnoeas
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Oxygen saturation recorded in the total sleep time
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
|
Oxygen Saturation
|
96.56 percentage SpO2
Standard Deviation 0.78
|
96.31 percentage SpO2
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
|
Percentage of Total Sleep Time Spent in Each Sleep Stage
Time spent in N1 Sleep
|
6.05 percentage of total sleep time
Standard Deviation 4.63
|
6.20 percentage of total sleep time
Standard Deviation 3.33
|
|
Percentage of Total Sleep Time Spent in Each Sleep Stage
Time spent in N2 Sleep
|
51.28 percentage of total sleep time
Standard Deviation 12.91
|
49.44 percentage of total sleep time
Standard Deviation 12.01
|
|
Percentage of Total Sleep Time Spent in Each Sleep Stage
Time spent in N3 Sleep
|
24.83 percentage of total sleep time
Standard Deviation 11.58
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24.60 percentage of total sleep time
Standard Deviation 10.77
|
|
Percentage of Total Sleep Time Spent in Each Sleep Stage
Time spent in REM Sleep
|
17.93 percentage of total sleep time
Standard Deviation 11.05
|
19.77 percentage of total sleep time
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.
Total number of respiratory event related arousals over the entire sleep period
Outcome measures
| Measure |
Standard AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
|
Modified AutoSet Algorithm
n=20 Participants
Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
|
|---|---|---|
|
Number of Respiratory Event Related Arousals
|
2.60 Respiratory-Event Related Arousals
Standard Deviation 3.32
|
1.30 Respiratory-Event Related Arousals
Standard Deviation 1.84
|
Adverse Events
Unblinded Investigational Arm
Standard AutoSet Algorithm
Modified AutoSet Then Standard AutoSet
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. David Hillman & Prof. Peter Eastwood
University of Western Australia
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has the right to * review * provide comments (site is not bound to follow them) * request delay of publication for no more than 120 days to allow for securing of IP * request the removal of specified confidential information within 40 days of the proposed publication being released to those not bound by confidentiality obligations.
- Publication restrictions are in place
Restriction type: OTHER