Prevalence, Severity and Natural Course of Sleep Apnea Af... | NCT02632162

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

NCT02632162

Sponsor

Zürcher RehaZentrum Wald

Status

Unknown status

Last Update Posted

Jul 12, 2016Estimated

Enrollment

450Estimated

Phase

Not provided

Conditions

Sleep Disordered Breathing

Interventions

screening

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 2, 2015

First Submission Date that Met QC Criteria

Dec 13, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac surgery		active Group screening	Other: screening
orthopedic surgery		control Group screening	Other: screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
screening	Other	Screening for sleep disordered breathing with the ApnoeLink Air device	cardiac surgery orthopedic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cardiac surgery or orthopedic surgery <2 weeks

Exclusion Criteria:

known SDB

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

cardiac surgery < 2 weeks

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthias Hermann, MD	Contact	+41 55 256	6802

Overall Officials

Name	Affiliation	Role
Matthias Hermann, MD	Zürcher RehaZentrum Wald	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zürcher RehaZentrum Wald	Recruiting	Wald		8636	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided