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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Unknown

Conditions

Resistant Hypertension
Sleep Apnea, Obstructive

Treatments

Device: type IV portable monitoring (Somnocheck micro Weinmann)

Study type

Interventional

Funder types

Other

Identifiers

NCT03257488
163/2014/O/Disp

Details and patient eligibility

About

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).

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

100 participants in 2 patient groups

Screening device-Traditional device
Active Comparator group
Description:
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.
Treatment:
Device: type IV portable monitoring (Somnocheck micro Weinmann)
Traditional device-Screening device
Active Comparator group
Description:
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.
Treatment:
Device: type IV portable monitoring (Somnocheck micro Weinmann)

Trial contacts and locations

1

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Central trial contact

Francesco Tavalazzi, Medical

Data sourced from clinicaltrials.gov

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