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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000407-57 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
| University Hospital, Angers | OTHER_GOV |
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The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.
Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APAP without SensAwake | Active Comparator | Auto CPAP delivered from the ICON+ CPAP device. |
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| APAP with SensAwake | Experimental | Auto CPAP with SensAwake turned on and set at a pressure of 4cmH2O. SensAwake is a pressure relief function that reduces the CPAP pressure on the transition from sleep to wake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APAP | Device | Automatic Continuous Positive Airway Pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Sleep Quality - Wake After Sleep Onset (WASO) | Amount of time spent awake after sleep onset, as measured by actigraphy | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Sleep Quality - Total Sleep Time | Total sleep time, as measured by actigraphy - nightly average | Four weeks |
| Objective Sleep Quality - Sleep Onset Latency | Time it takes to fall asleep, as measured by actigraphy - nightly average |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Pepin, MD | CHU du Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble | Grenoble | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| APAP with SensAwake | Device | Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods. |
|
|
| Four weeks |
| Objective Sleep Quality - Sleep efficiency | Percentage of time in bed spent asleep, as measured by actigraphy - nightly average | Four weeks |
| Treatment compliance | Time spent on CPAP treatment - nightly average | Four weeks |
| Subjective sleep quality - Pittsburgh Sleep Quality Index | Questionnaire | Four weeks |
| Insomnia severity - Insomnia Severity Index | Questionnaire | Four weeks |
| Daytime sleepiness - Epworth Sleepiness Score | Questionnaire | Four weeks |
| Quality of Life - Short Form 12 | Questionnaire | Four weeks |
| Blood pressure | Measured by 24 hour ambulatory blood pressure | 24 hours |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |