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| ID | Type | Description | Link |
|---|---|---|---|
| K53 | Other Identifier | Turku University Hospital |
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| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
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Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).
Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was >4 h/day, mask leak <0.4 L/s, and AHI <5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring | Experimental | After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device |
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| Usual care | No Intervention | Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring via wireless internet-based system | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Nursing time | Nursing time of the TM group was estimated as follows: patient education regarding ResTraxx™ Online system (2 min), online data check-ups (0.5 min), remote changes for pressure settings (1 min), telephone guidance (5 min for the end of monitoring, 10 min for each extra call), visit at the study nurse (30- 60 min depending on type of visit), updating the patient records (2 min), and no show visits, which led to organizing a new appointment (20min). The time estimations are based on the measurements of the first 20 telemonitored patients. Nursing time in the UC Group was estimated with the same time calculations as in the TM group presented above with the exception of ttelemonitoring time which was not applicable in the UC group. | One year after the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hours of CPAP use | Hours of CPAP use measured by the inbuilt counter of the CPAP device | One year after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Residual apnea-hypopnea index (AHI) | Maan AHI over 12 months according the CPAP-device | One year after baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20521 | Finland |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |