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Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female obstructive sleep apnea manifests differently than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device has been designed specifically to treat female OSA. In this Cohort study, female patients who are newly diagnosed with OSA will be asked to complete various questionnaires relating to their quality of life. Patients will then use the AutoSet for Her for three months. At the completion of the three months the questionnaires will be repeated. Before treatment and after treatment quality of life will be compared to determine if treating female specific OSA in these patients improves quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AutoSet for Her PAP device | Experimental | Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoSet for Her | Device | 3 months nightly usage of the AutoSet for Her device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Changes Assessed Through Polysomnography | assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Campos-Rodríguez, Prof | Hospital Universitario de Valme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep and Ventilation Center | Blaubeuren Abbey | Ulm | Germany | |||
| Advanced Sleep Research GmbH |
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A total of 122 patients (25 from Spain and 97 from Germany) were enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | AutoSet for Her PAP Device | Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AutoSet for Her PAP Device | Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device |
| 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 | Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
3 months
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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 | AutoSet for Her PAP Device | Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Medical Affairs | ResMed | +61 8884 1123 | alison.wimms@resmed.com |
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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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| Berlin |
| 10117 |
| Germany |
| Hospital Universitario de Valme. | Seville | 41014 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Sleep Changes Assessed Through Polysomnography | assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months | Posted | Mean | Standard Deviation | minutes | 3 months |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|