Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •implantable cardioverter-defibrillator (ICD),
- •pacemaker (PM),
- •previous diagnosis of OSAS,
- •pregnancy,
- •breastfeeding,
- •patients must not be already enrolled in other clinical trial.
Arms & Interventions
Screening device-Traditional device
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.
Intervention: type IV portable monitoring (Somnocheck micro Weinmann) (Device)
Traditional device-Screening device
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.
Intervention: type IV portable monitoring (Somnocheck micro Weinmann) (Device)
Outcomes
Primary Outcomes
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
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
Secondary Outcomes
- 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 2(Cardiovascular assessment must be done within 6 months before the sleep studies.)
Investigators
Francesco Tavalazzi
Medical Doctor
IRCCS Azienda Ospedaliero-Universitaria di Bologna