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This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).
OSAS is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.
OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these patients.
This study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to estimate the prevalence of OSAS among patients affected by resistant systemic arterial hypertension. The results are compared with a complete cardio-respiratory monitoring (type III portable monitoring: Somnocheck 2 Weinmann).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening device-Traditional device | Active Comparator | The patients included in the A Group will be studied during the first night with the screening device (type IV portable monitoring Somnocheck micro Weinmann) and with the traditional one during the following night. |
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| Traditional device-Screening device | Active Comparator | The patients included in the B Group will be studied during the first night with the traditional device and with the screening one (type IV portable monitoring Somnocheck micro Weinmann) during the following night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| type IV portable monitoring (Somnocheck micro Weinmann) | Device | Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one. | Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one. | These two procedures must be done in the same patient within 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with cardiovascular abnormalities 1 | Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring | Cardiovascular assessment must be done within 6 months before the sleep studies. |
| Number of Participants with cardiovascular abnormalities 2 |
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Inclusion Criteria:
Exclusion Criteria: ,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Tavalazzi, Medical | Contact | +390512143253 | francesco.tavalazzi@aosp.bo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda ospedaliera policlinico Sant'Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
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|
Number of Participants with cardiovascular abnormalities assessed by ecocardiography |
| Cardiovascular assessment must be done within 6 months before the sleep studies. |
| 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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