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| Name | Class |
|---|---|
| The University of Western Australia | OTHER |
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The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.
Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.
User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unblinded Investigational Arm | Experimental | 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 | Active Comparator | 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 algorithm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard AutoSet algorithm | Device | An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnoea Hypopnoea Index (AHI) | Number of apnoeas and hypopnoeas per hour of sleep | 1 day |
| Oxygen Desaturation Index (ODI) | Number of oxygen desaturations per hour of sleep | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficacy | Sleep time divided by total time available for sleep | 1 day |
| Wake After Sleep Onset Time | Time awake in minutes after initial sleep onset |
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Inclusion Criteria:
Exclusion Criteria:
Participants currently using Bi-level PAP
Participants currently using supplemental oxygen
Participants who are pregnant
Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
Participants who the researcher believes are unsuitable for inclusion because either:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Eastwood, MBBS FRACP | Centre for Sleep Science, University of Western Australia | Principal Investigator |
| David Hillman, MBBS FRACP | West Australian Sleep Disorders Reserach Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Australian Sleep Disorders Research Institute | Nedlands | Western Australia | 6009 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnoea Hypopnoea Index (AHI) | Number of apnoeas and hypopnoeas per hour of sleep | 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. | Posted | Mean | Standard Deviation | events/hour | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. David Hillman & Prof. Peter Eastwood | University of Western Australia | +61 8 9346 1706 | peter.eastwood@health.wa.gov.au |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Modified AutoSet algorithm | Device | An AutoSet device with an algorithm developed for sleep breathing parameters specific to females. |
|
|
| 1 day |
| Time Taken to Fall Asleep | Time in minutes taken to fall alseep | 1 day |
| Number of Spontaneous Arousals | Number of spontaneous arousals occurring over the entire total sleep time | 1 day |
| Number of Hypopnoeas | Total number of hypopnoeas occurring in the total sleep time | 1 day |
| Number of Obstructive Apnoeas | Total number of obstructive apnoeas occurring in the total sleep time | 1 day |
| Number of Central Apnoeas | Total number of central apnoeas occurring in the total sleep time | 1 day |
| Oxygen Saturation | Oxygen saturation recorded in the total sleep time | 1 day |
| Percentage of Total Sleep Time Spent in Each Sleep Stage | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) | 1 day |
| Number of Respiratory Event Related Arousals | Total number of respiratory event related arousals over the entire sleep period | 1 day |
| BG001 |
| 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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Oxygen Desaturation Index (ODI) | Number of oxygen desaturations per hour of sleep | 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. | Posted | Mean | Standard Deviation | events/hour | 1 day |
|
|
|
| Secondary | Sleep Efficacy | Sleep time divided by total time available for sleep | 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. | Posted | Mean | Standard Deviation | percentage of total recorded time | 1 day |
|
|
|
| Secondary | Wake After Sleep Onset Time | Time awake in minutes after initial sleep onset | 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. | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
|
| Secondary | Time Taken to Fall Asleep | Time in minutes taken to fall alseep | 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. | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
|
| Secondary | Number of Spontaneous Arousals | Number of spontaneous arousals occurring over the entire total sleep time | 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. | Posted | Mean | Standard Deviation | Spontaneous Arousals | 1 day |
|
|
|
| Secondary | Number of Hypopnoeas | Total number of hypopnoeas occurring in the total sleep time | 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. | Posted | Mean | Standard Deviation | Hypopneas | 1 day |
|
|
|
| Secondary | Number of Obstructive Apnoeas | Total number of obstructive apnoeas occurring in the total sleep time | 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. | Posted | Mean | Standard Deviation | Obstructive Apnoeas | 1 day |
|
|
|
| Secondary | Number of Central Apnoeas | Total number of central apnoeas occurring in the total sleep time | 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. | Posted | Mean | Standard Deviation | Central Apnoeas | 1 day |
|
|
|
| Secondary | Oxygen Saturation | Oxygen saturation recorded in the total sleep time | 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. | Posted | Mean | Standard Deviation | percentage SpO2 | 1 day |
|
|
|
| Secondary | Percentage of Total Sleep Time Spent in Each Sleep Stage | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) | 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. | Posted | Mean | Standard Deviation | percentage of total sleep time | 1 day |
|
|
|
| Secondary | Number of Respiratory Event Related Arousals | Total number of respiratory event related arousals over the entire sleep period | 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. | Posted | Mean | Standard Deviation | Respiratory-Event Related Arousals | 1 day |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 |
The Sponsor has the right to
within 40 days of the proposed publication being released to those not bound by confidentiality obligations.
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Time spent in N3 Sleep |
|
| Time spent in REM Sleep |
|