Sleep-related Breathing Disorders in Cardiological Outpatients

NCT ID: NCT02693925

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-16

Study Completion Date

2018-09-28

Brief Summary

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The purpose of this study is to determine the prevalence of sleep-related breathing disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of polygraphy.

Furthermore, the practicability of the underlying diagnostic process in clinical application is assessed as well as the sensitivity and specificity of polygraphy as compared to the reference standard of polysomnography. Another aim is to determine the individual cardiovascular risk profile by pulse wave analysis and risk classification according to European Society of Hypertension (ESH) and European Society of Cardiology (ESC), "ESH/ESC risk".

Detailed Description

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Conditions

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Sleep Apnea Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Present chronic cardiovascular disease (incl. but not limited to: ischemic heart disease, arterial hypertension, heart failure, atrial fibrillation)
* Current clinically stable state (incl. patients after a cardiovascular-related, emergency hospital admission and subsequent recompensation towards the end of their hospital stay

Exclusion Criteria

* Age \<18 years
* Acute life-threatening disease (incl. but not limited to:instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association (NYHA) stage IV, myocardial infarction, exacerbated chronic obstructive pulmonary disease (COPD), Malignant disease requiring treatment)
* Pregnancy and/or lactation
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Clinic Cologne

UNKNOWN

Sponsor Role collaborator

Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winfried J Randerath, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Wissenschaftliches Institut Bethanien e.V

Locations

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University Clinic Cologne, Heart Center

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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WI_SBASKardio_14-322

Identifier Type: -

Identifier Source: org_study_id

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