NCT03257488

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sleep Apnea, Obstructive
• Resistant Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2017-08-22
• Last updated: 2017-08-22

Locations

1 site across 1 country: Italy