Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
NCT ID: NCT03257488
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-04-30
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome
NCT03632382
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
NCT05595200
Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
NCT00929175
Prospective National Multi-center Registry of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China
NCT05735444
Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
NCT05918120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must sign the informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Tavalazzi
Medical Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azienda ospedaliera policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
163/2014/O/Disp
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.