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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02632162
- Acronym / sponsor ID
- SDB-ZRW / ZRW-SDB-2015
- Conditions
- Sleep Disordered Breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Zürcher RehaZentrum WaldUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | – | Other: screeningactive Group screening |
| orthopedic surgery | – | Other: screeningcontrol Group screening |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cardiac surgery < 2 weeks
Key inclusion criteria (1 listed)
- cardiac surgery or orthopedic surgery <2 weeks
Key exclusion criteria (1 listed)
- known SDB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screeningScreening for sleep disordered breathing with the ApnoeLink Air device | Other | cardiac surgery, orthopedic surgery |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Hermann, MD principal investigator
Zürcher RehaZentrum Wald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing, run by Zürcher RehaZentrum Wald at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SDB prevalence after cardiac surgery measured with ApnoeLink Air device (time frame: day 1, day 20, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.