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NCT02632162 Clinical Trial

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

Sleep Disordered Breathing Clinical Trial

— SDB-ZRW  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02632162
Other study ID # ZRW-SDB-2015
Secondary ID
Status Recruiting
Phase N/A
First received December 2, 2015
Last updated July 11, 2016
Start date May 2016
Est. completion date December 2017

Study information
Verified date July 2016
Source Zürcher RehaZentrum Wald
Contact Matthias Hermann, MD
Phone +41 55 256
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- cardiac surgery or orthopedic surgery <2 weeks

Exclusion Criteria:

- known SDB

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• screening
Screening for sleep disordered breathing with the ApnoeLink Air device

Locations
Country Name City State
Switzerland Zürcher RehaZentrum Wald Wald

Sponsors (1)
Lead Sponsor Collaborator
Zürcher RehaZentrum Wald

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of SDB prevalence after cardiac surgery measured with ApnoeLink Air device • 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 No
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