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Clinical Trials/NCT02693925
NCT02693925
Completed
Not Applicable

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

Wissenschaftliches Institut Bethanien e.V1 site in 1 country90 target enrollmentDecember 16, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea Syndromes
Sponsor
Wissenschaftliches Institut Bethanien e.V
Enrollment
90
Locations
1
Primary Endpoint
Prevalence of sleep-related breathing disorders
Status
Completed
Last Updated
7 years ago

Overview

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".

Registry
clinicaltrials.gov
Start Date
December 16, 2014
End Date
September 28, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wissenschaftliches Institut Bethanien e.V
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Number of patients included(through study completion, an average of 21 months)
  • Number of patients with actually performed polygraphy(through study completion, an average of 21 months)
  • Number of patients with assessable polygraphy(through study completion, an average of 21 months)
  • Number of patients with actually performed polysomnography(through study completion, an average of 21 months)
  • Number of patients with assessable polysomnography(through study completion, an average of 21 months)

Study Sites (1)

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