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

Not Applicable

• Conditions: Sleep Apnea, Obstructive; Resistant Hypertension
• Interventions: Device: type IV portable monitoring (Somnocheck micro Weinmann)

• Registration Number: NCT03257488
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-02-10
• Status Verified: 2017-07
• Study First Submitted QC: 2017-08-21
• Last Update Submitted: 2017-08-21
• Study First Posted: 2017-08-22
• Last Update Posted: 2017-08-22
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Screening device-Traditional device	type IV portable monitoring (Somnocheck micro Weinmann)	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.
Traditional device-Screening device	type IV portable monitoring (Somnocheck micro Weinmann)	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.

Primary Outcome Measures

Name	Time	Method
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	Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with cardiovascular abnormalities 1	Cardiovascular assessment must be done within 6 months before the sleep studies.	Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring
Number of Participants with cardiovascular abnormalities 2	Cardiovascular assessment must be done within 6 months before the sleep studies.	Number of Participants with cardiovascular abnormalities assessed by ecocardiography

Trial Locations

Locations (1)

Azienda ospedaliera policlinico Sant'Orsola-Malpighi; 🇮🇹 Bologna, Italy