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The site closed down, therefore the study has been terminated.
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| Name | Class |
|---|---|
| Sleep Health Centers | OTHER |
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A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional CPAP | Placebo Comparator | Fisher & Paykel HC244™ |
|
| CPAP without Humidification | Active Comparator | Fixed pressure ICON™ without ThermoSmart™ |
|
| APAP with all technologies | Experimental | Auto ICON™ with SensAwake™ and ThermoSmart™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional CPAP Therapy | Device | HC244 devices without Thermosmart or SensAwake |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software. | On day 90 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit. | On day 90 after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep HealthCenters | Brighton | Massachusetts | 02135 | United States |
This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional CPAP | Fisher & Paykel HC244™ Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake |
| FG001 | CPAP Without Humidification | Fixed pressure ICON™ without ThermoSmart™ Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fixed pressure ICON™ without ThermoSmart™ |
| Device |
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™ |
|
| Auto ICON™ with SensAwake™ and ThermoSmart™ | Device | APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™ |
|
| FG002 | APAP With All Technologies | Auto ICON™ with SensAwake™ and ThermoSmart™ Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™ |
| COMPLETED |
|
| NOT COMPLETED |
|
This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional CPAP | Fisher & Paykel HC244™ Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake |
| BG001 | CPAP Without Humidification | Fixed pressure ICON™ without ThermoSmart™ Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™ |
| BG002 | APAP With All Technologies | Auto ICON™ with SensAwake™ and ThermoSmart™ Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™ |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| ||||||||||||||||||||||
| Age, Continuous | |||||||||||||||||||||||
| Sex: Female, Male |
| ||||||||||||||||||||||
| Region of Enrollment | 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 | Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software. | This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists. | Posted | On day 90 after randomization |
|
| ||||||||||||||||||||||||||
| Secondary | Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit. | This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists. | Posted | On day 90 after randomization |
|
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This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
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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 | Conventional CPAP | Fisher & Paykel HC244™ Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | CPAP Without Humidification | Fixed pressure ICON™ without ThermoSmart™ Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™ | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | APAP With All Technologies | Auto ICON™ with SensAwake™ and ThermoSmart™ Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™ | 0 | 0 | 0 | 0 | 0 | 0 |
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This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher and Paykel Healthcare | +64 09 574 0100 | CPAPtrial@fphcare.co.nz |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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