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

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).

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive; Resistant Hypertension
• Intervention / Treatment: Device: type IV portable monitoring (Somnocheck micro 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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Azienda ospedaliera policlinico Sant'Orsola-Malpighi
    • Contact: Francesco Tavalazzi, medical; Phone Number: +300512143252; Email: francesco.tavalazzi@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Screening device-Traditional device; 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); Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.; Other Names: type III portable monitoring (Somnocheck 2 Weinmann)
Active Comparator: Traditional device-Screening device; 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); Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.; Other Names: type III portable monitoring (Somnocheck 2 Weinmann)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea
• Other Study ID Numbers: 163/2014/O/Disp