To Investigate the Incidence of Obstructive Sleep Apnoea... | NCT01829854

Studies
To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery

NCT01829854

Sponsor

University of Malaya

Status

Unknown status

Last Update Posted

Apr 11, 2013Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnoea

Interventions

Not provided

Countries

Malaysia

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

Apr 2013

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

Jun 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

Apr 10, 2013

First Posted Date

Apr 11, 2013Estimated

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

Apr 10, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open heart surgery .

Detailed Description

Not provided

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

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Obstructive Sleep Apnoea	To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery .	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults male and female , aged 45 years old and above
undergoing open heart surgery that requires hospital stays of more than 5 days

Exclusion Criteria:

previous diagnosis and treatment of OSA or any sleep related breathing disorder.
unwilling or physically unavailable for polysomnography before surgery.
Patient undergoing MAZE procedure .
Patient with severe COPD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient undergoing open heart surgery and is more than 45 years old . These patient are also required to stay in hospital for more than 5 days .

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Sukcharanjit Singh, MD,MMed(Anaes)	Contact	0060126543142		sukcharan07@yahoo.com.my
Dr Sivakumar Krishnasamy, MBBS,MMed(Surgery)	Contact	0060173453839		sivaprotoss@yahoo.com

Overall Officials

Name	Affiliation	Role
Sivakumar Krishnasamy, MD, MMed(Surgery)	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Malaya Medical Centre	Recruiting	Kuala Lumpur	Kuala Lumpur	59100	Malaysia

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided