Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
Primary Purpose
Sleep Apnea, Obstructive, Resistant Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
type IV portable monitoring (Somnocheck micro Weinmann)
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea, Obstructive
Eligibility 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.
Sites / Locations
- Azienda ospedaliera policlinico Sant'Orsola-MalpighiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Screening device-Traditional device
Traditional device-Screening device
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants with cardiovascular abnormalities 1
Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring
Number of Participants with cardiovascular abnormalities 2
Number of Participants with cardiovascular abnormalities assessed by ecocardiography
Full Information
NCT ID
NCT03257488
First Posted
February 10, 2017
Last Updated
August 21, 2017
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03257488
Brief Title
Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
Official Title
Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Resistant Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening device-Traditional device
Arm Type
Active Comparator
Arm 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.
Arm Title
Traditional device-Screening device
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
type IV portable monitoring (Somnocheck micro Weinmann)
Other Intervention Name(s)
type III portable monitoring (Somnocheck 2 Weinmann)
Intervention Description
Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.
Primary Outcome Measure Information:
Title
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants with cardiovascular abnormalities 1
Description
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.
Title
Number of Participants with cardiovascular abnormalities 2
Description
Number of Participants with cardiovascular abnormalities assessed by ecocardiography
Time Frame
Cardiovascular assessment must be done within 6 months before the sleep studies.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Tavalazzi, Medical
Phone
+390512143253
Email
francesco.tavalazzi@aosp.bo.it
Facility Information:
Facility Name
Azienda ospedaliera policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Tavalazzi, medical
Phone
+300512143252
Email
francesco.tavalazzi@aosp.bo.it
12. IPD Sharing Statement
Learn more about this trial
Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
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