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

NCT ID: NCT02632162

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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

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Sleep Disordered Breathing

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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cardiac surgery

active Group screening

screening

Intervention Type OTHER

Screening for sleep disordered breathing with the ApnoeLink Air device

orthopedic surgery

control Group screening

screening

Intervention Type OTHER

Screening for sleep disordered breathing with the ApnoeLink Air device

Interventions

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screening

Screening for sleep disordered breathing with the ApnoeLink Air device

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* cardiac surgery or orthopedic surgery \<2 weeks

Exclusion Criteria

* known SDB
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zürcher RehaZentrum Wald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Hermann, MD

Role: PRINCIPAL_INVESTIGATOR

Zürcher RehaZentrum Wald

Locations

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Zürcher RehaZentrum Wald

Wald, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Matthias Hermann, MD

Role: CONTACT

+41 55 256 ext. 6802

Facility Contacts

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Matthias Hermann, MD

Role: primary

[email protected]
+4155256 ext. 6802

Other Identifiers

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ZRW-SDB-2015

Identifier Type: -

Identifier Source: org_study_id

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