Sleep-related Breathing Disorders in Cardiological Outpatients

NCT02693925 | Completed

• 1 other identifier: WI_SBASKardio_14-322
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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".

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• Prevalence of sleep-related breathing disorders

  Prevalence of sleep-related breathing disorders as measured by ambulatory polygraphy and defined as an respiratory disturbance index of \>=15/h

  Once within two days of inclusion

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead
• University Clinic Cologne: collaborator

Study Sites (1)

University Clinic Cologne, Heart Center

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Winfried J Randerath, Prof. Dr.

  Wissenschaftliches Institut Bethanien e.V

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 29, 2016
• Study Start: December 16, 2014
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)