- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01829854
To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery
April 10, 2013 updated by: University of Malaya
Unrecognised Obstructive Sleep Apnoea In Cardiac Surgery Patient In The Asian Population
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 .
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wilayah Persekutuan
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Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
-
Contact:
- Dr Sivakumar Krishnasamy, MBBS,MMed(Surgery)
- Phone Number: 0060173453839
- Email: sivaprotoss@yahoo.com
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Contact:
- Sukcharanjit Singh, MD,MMed(Anaes)
- Phone Number: 0060126543142
- Email: sukcharan07@yahoo.com.my
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Sub-Investigator:
- Sukcharanjit Singh, MD,MMed(Anaes)
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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 .
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Obstructive Sleep Apnoea
Time Frame: 2 years
|
To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery .
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sivakumar Krishnasamy, MD, MMed(Surgery), University of Malaya
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
April 9, 2013
First Submitted That Met QC Criteria
April 10, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Estimate)
April 11, 2013
Last Update Submitted That Met QC Criteria
April 10, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG423-12HTM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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