Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery

• Conditions: Sleep Disordered Breathing

• Registration Number: NCT02632162
• Lead Sponsor: Zürcher RehaZentrum Wald

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-13
• Study First Posted: 2015-12-16
• Study Start: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• cardiac surgery or orthopedic surgery <2 weeks

Exclusion Criteria

• known SDB

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of SDB prevalence after cardiac surgery measured with ApnoeLink Air device	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)

Trial Locations

Locations (1)

Zürcher RehaZentrum Wald; 🇨🇭 Wald, Switzerland