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NCT01829854 Clinical Trial

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

Obstructive Sleep Apnoea Clinical Trial

Official title:
Unrecognised Obstructive Sleep Apnoea In Cardiac Surgery Patient In The Asian Population

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01829854
Other study ID # RG423-12HTM
Secondary ID
Status Recruiting
Phase N/A
First received April 9, 2013
Last updated April 10, 2013
Start date June 2012
Est. completion date June 2014

Study information
Verified date April 2013
Source University of Malaya
Contact Dr Sukcharanjit Singh, MD,MMed(Anaes)
Phone 0060126543142
Email sukcharan07@yahoo.com.my
Is FDA regulated No
Health authority Malaysia : Medical Ethics Committee
Study type Observational

Clinical Trial 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 .

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date June 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Malaysia University Malaya Medical Centre Kuala Lumpur Wilayah Persekutuan

Sponsors (1)
Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Obstructive Sleep Apnoea To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery . 2 years Yes
See also
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