Sleep Disordered BreathingSDB-ZRWNCT02632162
Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery
An observational study of Sleep Disordered Breathing, run by Zürcher RehaZentrum Wald at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- screening
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Dec 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cardiac surgery < 2 weeks
Who may be able to join
- cardiac surgery or orthopedic surgery <2 weeks
Who cannot join
- known SDB
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Sleep Disordered Breathing
- Being tested
- screening
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screeningOther
Screening for sleep disordered breathing with the ApnoeLink Air device
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | active Group screening Receives: Other: screening | |
| orthopedic surgery | control Group screening Receives: Other: screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 1, day 20, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionAug 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zürcher RehaZentrum Wald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Hermann, MD, Principal investigator, Zürcher RehaZentrum Wald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632162
- Sponsor's protocol ID
- ZRW-SDB-2015
- Acronym
- SDB-ZRW
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2015
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No