Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery (SDB-ZRW)

July 11, 2016 updated by: Zürcher RehaZentrum Wald
Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after cardiac surgery will be screened for SDB with the ApnoeLink device at the beginning of cardiac Rehabilitation and then after 3 weeks and 3 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective(s) of the project

  • Evaluate the prevalence of sleep apnea after cardiac surgery
  • Compare results interindividually (group A vs. group B) and intraindividually (longitudinal assessment after 3 months)

Outcome(s)

  • Prevalence of sleep apnoe at day 1 and 20 of rehabilitation and 3 months after cardiac surgery
  • composite endpoint of events at 3 months (cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, revascularisation procedure, new atrial fibrillation and stroke)
  • change in 6-minute walking test (6-MWT)
  • impact of heart surgery on sleep apnoe

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

cardiac surgery < 2 weeks

Description

Inclusion Criteria:

  • cardiac surgery or orthopedic surgery <2 weeks

Exclusion Criteria:

  • known SDB

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cardiac surgery
active Group screening
Other: screening
Screening for sleep disordered breathing with the ApnoeLink Air device
orthopedic surgery
control Group screening
Other: screening
Screening for sleep disordered breathing with the ApnoeLink Air device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of SDB prevalence after cardiac surgery measured with ApnoeLink Air device
Time Frame: day 1, day 20, 3 months
• Prevalence of sleep apnoe at day 1 and 20 of rehabilitation and 3 months after cardiac surgery assessed with the ApnoeLink Air device (ResMed)
day 1, day 20, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zürcher RehaZentrum Wald

Investigators

  • Principal Investigator: Matthias Hermann, MD, Zürcher RehaZentrum Wald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 13, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZRW-SDB-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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