NCT01830036

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

5.5 years

First QC Date

April 9, 2013

Last Update Submit

September 22, 2015

Conditions

Sleep Apnea

Keywords

cardiological treatmentsleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Quality of Life (SF12), 2-channel Polygraphy

cardiological treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Treatment as part of the routine diagnostics using 2-channel polygraphic

You may qualify if:

  • terminal cardiac treatment in cardiac rehabilitation facility
  • for example: Myocardial infarction, bypass surgery, stent implantation, valve replacement, ICD, CRT, pacemakers, heart failure

You may not qualify if:

  • no informed consent form signed
  • limited consent capacity (Dementia, addiction, psychosis)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Stefan Krüger, Univ.-Prof.

    University Hospital Aachen, Medical Clinic I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

June 1, 2011

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

September 23, 2015

Record last verified: 2015-09