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RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation (RehaSleep)

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ClinicalTrials.gov Identifier: NCT01830036
Recruitment Status : Unknown
Verified September 2015 by RWTH Aachen University.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2013
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
RWTH Aachen University

Brief 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.


Condition or disease
Sleep Apnea

Study Type : Observational [Patient Registry]
Actual Enrollment : 1300 participants
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation
Study Start Date : June 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Quality of Life (SF12), 2-channel Polygraphy
cardiological treatment



Primary Outcome Measures :
  1. cardiological treatment [ Time Frame: April 2013 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment as part of the routine diagnostics using 2-channel polygraphic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830036


Sponsors and Collaborators
RWTH Aachen University
ResMed
Investigators
Principal Investigator: Stefan Krüger, Univ.-Prof. University Hospital Aachen, Medical Clinic I

Additional Information:
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01830036     History of Changes
Other Study ID Numbers: 10-007
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by RWTH Aachen University:
cardiological treatment
sleep Apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases