Sleep-related Breathing Disorders in Cardiological Outpatients (SRBD-Cardio)

Sleep-related Breathing Disorders in Cardiological Outpatients From a German University Clinic - Prevalence, Classification, Diagnostic Accuracy

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".

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Clinic Cologne, Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cardiologic diseases who have a routine outpatient follow-up visit in the heart center of the University Clinic Cologne or are at the end of a cardivascular-related hospital stay in stable (recompensated) state.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of sleep-related breathing disorders	Prevalence of sleep-related breathing disorders as measured by ambulatory polygraphy and defined as an respiratory disturbance index of >=15/h	Once within two days of inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients included	Total number of patients included in the study after overall study conclusion	through study completion, an average of 21 months
Number of patients with actually performed polygraphy	Total number of patients in whom ambulatory polygraphy was actually performed, after overall study conclusion	through study completion, an average of 21 months
Number of patients with assessable polygraphy	Total number of patients in whom ambulatory polygraphy was assessable, after overall study conclusion	through study completion, an average of 21 months
Number of patients with actually performed polysomnography	Total number of patients in whom stationary polysomnography was actually performed, after overall study conclusion	through study completion, an average of 21 months
Number of patients with assessable polysomnography	Total number of patients in whom stationary polysomnography was assessable, after overall study conclusion	through study completion, an average of 21 months

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Collaborators: University Clinic Cologne

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2014
• Primary Completion (Actual): September 28, 2016
• Study Completion (Actual): September 28, 2018

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: WI_SBASKardio_14-322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO