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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03257488
• Other study ID #: 163/2014/O/Disp
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2017
• Last updated: August 21, 2017
• Start date: April 2015
• Est. completion date: February 2019

Study information

• Verified date: July 2017
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Francesco Tavalazzi, Medical
• Phone: +390512143253
• Email: francesco.tavalazzi[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Resistant Hypertension
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda ospedaliera policlinico Sant'Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.