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The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nexus Flow Generator | Experimental | Participants were randomised to Nexus Flow Generator group for one night. |
|
| VPAP Flow Generator 25 | Active Comparator | Participants were randomised to VPAP Flow Generator 25 group for one night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexus Flow Generator | Device | The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnoea-Hypopnoea Index (AHI) | The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25 | One Night On Each Arm, approximately 8 hours each night |
| Oxygen Desaturation Index | Number of oxygen desaturations per hour of sleep | One Night On Each Arm, approximately 8 hours each night |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort of Breathing | 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 | One Night On Each Arm, approximately 8 hours each night |
| Satisfaction of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are unable to provide written informed consent
Patients who are unable to comprehend written and spoken English
Patients who are using Bilevel PAP
Patients who are pregnant
Patients who are suffering any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, PhD | ResMed/The University of New South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Healthy Sleep | Bella Vista | New South Wales | 2135 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This was a cross-over study, therefore all participants were assigned to both interventions, for one night each, in a randomised order |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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) | The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25 | Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode. | Posted | Mean | Standard Deviation | Events/Hour | One Night On Each Arm, approximately 8 hours each night |
|
2 consecutive nights
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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 | Nexus Flow Generator | Modified AutoSet for the treatment of OSA. Participants used this device while sleeping for one night. No Adverse Events were reported during the trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Wimms | ResMed Ltd | +44 7901332675 | alison.wimms@resmed.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| VPAP Flow Generator 25 | Device | Exiting VPAP Auto 25 Flow Generator with A10 Algorithm |
|
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 |
| One Night On Each Arm, approximately 8 hours each night |
| Refreshed Feel | Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning? | One Night On Each Arm, approximately 8 hours each night |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Oxygen Desaturation Index | Number of oxygen desaturations per hour of sleep | Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode. | Posted | Mean | Standard Deviation | Events/Hour | One Night On Each Arm, approximately 8 hours each night |
|
|
|
| Secondary | Comfort of Breathing | 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 | Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode. | Posted | Median | Full Range | Scores on a Scale | One Night On Each Arm, approximately 8 hours each night |
|
|
|
| Secondary | Satisfaction of Treatment | 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 | Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode. | Posted | Median | Full Range | Scores on a scale | One Night On Each Arm, approximately 8 hours each night |
|
|
|
| Secondary | Refreshed Feel | Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning? | Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode. | Posted | Median | Full Range | Scores on a scale | One Night On Each Arm, approximately 8 hours each night |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | VPAP Flow Generator 25 | Standard AutoSet for the treatment of OSA. Participants used this device while sleeping for one night. No adverse events were reported during the trial | 0 | 20 | 0 | 20 | 0 | 20 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |