Clinical trial NCT02693925: Sleep-related Breathing Disorders in Cardiological Outpatients
Official title: Sleep-related Breathing Disorders in Cardiological Outpatients From a German University Clinic - Prevalence, Classification, Diagnostic Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: University Clinic Cologne
First posted: 2016-02-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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".


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

Primary outcomes:
measure: Prevalence of sleep-related breathing disorders
timeFrame: Once within two days of inclusion
Secondary outcomes:
measure: Number of patients included
timeFrame: through study completion, an average of 21 months
measure: Number of patients with actually performed polygraphy
timeFrame: through study completion, an average of 21 months
measure: Number of patients with assessable polygraphy
timeFrame: through study completion, an average of 21 months
measure: Number of patients with actually performed polysomnography
timeFrame: through study completion, an average of 21 months
measure: Number of patients with assessable polysomnography
timeFrame: through study completion, an average of 21 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Clinic Cologne, Heart Center
state: NRW
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: