NCT02632162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

December 2, 2015

Last Update Submit

July 11, 2016

Conditions

Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

cardiac surgery

active Group screening

Other: screening

orthopedic surgery

control Group screening

Other: screening

Interventions

screeningOTHER

Screening for sleep disordered breathing with the ApnoeLink Air device

cardiac surgeryorthopedic surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cardiac surgery \< 2 weeks

You may qualify if:

  • cardiac surgery or orthopedic surgery \<2 weeks

You may not qualify if:

  • known SDB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zürcher RehaZentrum Wald

Wald, 8636, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Matthias Hermann, MD

    Zürcher RehaZentrum Wald

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Hermann, MD

CONTACT

+41 55 256

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 16, 2015

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CH(1)