An interventional study of type IV portable monitoring (Somnocheck micro Weinmann) in Sleep Apnea, Obstructive and Resistant Hypertension, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Diagnostic
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).
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).
Inclusion Criteria:
Exclusion Criteria: ,
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)
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.
Also known as: type III portable monitoring (Somnocheck 2 Weinmann)
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.
Time frame: These two procedures must be done in the same patient within 5 days
Number of Participants with cardiovascular abnormalities 1
Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring
Time frame: 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
Time frame: Cardiovascular assessment must be done within 6 months before the sleep studies.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna