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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03257488

Enrollment

100

Registered

2017-08-22

Start date

2015-04-30

Completion date

2019-02-28

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Hypertension, Sleep Apnea, Obstructive

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).

Interventions

DEVICEtype 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactFrancesco Tavalazzi, Medical

francesco.tavalazzi@aosp.bo.it+390512143253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026