Sleep-related Breathing Disorders in Cardiological Outpatients

Completed

• Conditions: Sleep Apnea Syndromes

• Registration Number: NCT02693925
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-12-16
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Primary Completion: 2016-09-28
• Study Completion: 2018-09-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinic Cologne, Heart Center; 🇩🇪 Cologne, NRW, Germany