Sleep Apnea Syndromes
Conditions
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.
Interventions
None listed
Sponsors
University Clinic Cologne
Wissenschaftliches Institut Bethanien e.V
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
Germany
Outcome results
None listed