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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Resistant Hypertension; Sleep Apnea, Obstructive

Treatments: Device: type IV portable monitoring (Somnocheck micro Weinmann)

Study type: Interventional

Funder types: Other

Identifiers

NCT03257488

163/2014/O/Disp

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Screening device-Traditional device

Active Comparator group

Description:

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.

Treatment:

Device: type IV portable monitoring (Somnocheck micro Weinmann)

Traditional device-Screening device

Active Comparator group

Description:

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.

Treatment:

Device: type IV portable monitoring (Somnocheck micro Weinmann)