Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study

Conditions
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Sleep Apnea, Obstructive, Resistant Hypertension

Intervention / Treatment
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* Device: type IV portable monitoring (Somnocheck micro Weinmann)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resistant Arterial Hypertension Patients must sign the informed consent Exclusion Criteria: , atrial fibrillation with haemodynamic instability congestive hearth failure, BMI>45 kg/m2, respiratory failure renal or liver failure, stroke, implantable cardioverter-defibrillator (ICD), pacemaker (PM), previous diagnosis of OSAS, pregnancy, breastfeeding, patients must not be already enrolled in other clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Screening device-Traditional device<br>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. | Device: type IV portable monitoring (Somnocheck micro Weinmann)<br>* Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.<br>* Other names: type III portable monitoring (Somnocheck 2 Weinmann);|
| Active Comparator: Traditional device-Screening device<br>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. | Device: type IV portable monitoring (Somnocheck micro Weinmann)<br>* Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.<br>* Other names: type III portable monitoring (Somnocheck 2 Weinmann);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Number of Participants with cardiovascular abnormalities assessed by ecocardiography | Cardiovascular assessment must be done within 6 months before the sleep studies. |