Skip to main content
OpenTrials
Completed

NCT Number: NCT02693925

Sleep-related Breathing Disorders in Cardiological Outpatients

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".

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic Cologne, Heart Center

Cologne, North Rhine-Westphalia, 50937, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of sleep-related breathing disorders

    Time frame: 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 outcomes

  1. Number of patients included

    Time frame: through study completion, an average of 21 months

    Total number of patients included in the study after overall study conclusion

  2. Number of patients with actually performed polygraphy

    Time frame: through study completion, an average of 21 months

    Total number of patients in whom ambulatory polygraphy was actually performed, after overall study conclusion

  3. Number of patients with assessable polygraphy

    Time frame: through study completion, an average of 21 months

    Total number of patients in whom ambulatory polygraphy was assessable, after overall study conclusion

  4. Number of patients with actually performed polysomnography

    Time frame: through study completion, an average of 21 months

    Total number of patients in whom stationary polysomnography was actually performed, after overall study conclusion

  5. Number of patients with assessable polysomnography

    Time frame: through study completion, an average of 21 months

    Total number of patients in whom stationary polysomnography was assessable, after overall study conclusion

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

  • University Clinic Cologne

Registry information

Official study title

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

Acronym: SRBD-Cardio

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.