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NCT01830036 Clinical Trial

RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation

Sleep Apnea Clinical Trial

— RehaSleep  

Official title:
RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01830036
Other study ID # 10-007
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 9, 2013
Last updated September 22, 2015
Start date June 2011
Est. completion date April 2017

Study information
Verified date September 2015
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

Prevalence of sleep-related breath disturbance in patients in cardiac rehabilitation.

The aim of the register is to enable a better diagnosis and early treatment initiation in the context of secondary prevention. In addition to the prevalence, the further course of the patients shall be documented after hospital discharge to verify any gaps (sleep laboratory, therapy introduction) and emphasize the importance of rehabilitation and to examine the possibility of initiating therapy in rehabilitation.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1300
Est. completion date April 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- terminal cardiac treatment in cardiac rehabilitation facility

- for example: Myocardial infarction, bypass surgery, stent implantation, valve replacement, ICD, CRT, pacemakers, heart failure

Exclusion Criteria:

- no informed consent form signed

- limited consent capacity (Dementia, addiction, psychosis)

- pregnancy

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
RWTH Aachen University ResMed

Outcome
Type Measure Description Time frame Safety issue
Primary cardiological treatment all Patients who are admitted under a terminal cardiac treatment (myocardial infarction, bypass surgery, stent implantation, valve replacement, ICD, CRT) in a cardiac rehabilitation faciliy April 2013 No
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