Obstructive Sleep ApnoeaNCT01829854
To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery
An observational study of Obstructive Sleep Apnoea, run by University of Malaya at 1 site in Malaysia.
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 . Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Obstructive Sleep Apnoea
- How many people
- 400 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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 .
Who may be able to join
- adults male and female , aged 45 years old and above
- undergoing open heart surgery that requires hospital stays of more than 5 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Sukcharanjit Singh, MD,MMed(Anaes), 0060126543142, sukcharan07@yahoo.com.my
Dr Sivakumar Krishnasamy, MBBS,MMed(Surgery), 0060173453839, sivaprotoss@yahoo.com
About this study
Official title: 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 .
- Conditions
- Obstructive Sleep Apnoea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Obstructive Sleep Apnoea
To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sivakumar Krishnasamy, MD, MMed(Surgery), Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829854
- Sponsor's protocol ID
- RG423-12HTM
- Status last verified
- Apr 2013
- First submitted
- 9 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unrecognised Obstructive Sleep Apnoea In Cardiac Surgery Patient In The Asian Population
- ClinicalTrials.gov ID
- NCT01829854
- Acronym / sponsor ID
- RG423-12HTM
- Conditions
- Obstructive Sleep Apnoea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 .
Key inclusion criteria (2 listed)
- adults male and female , aged 45 years old and above
- undergoing open heart surgery that requires hospital stays of more than 5 days
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Obstructive Sleep Apnoea
Time frame: 2 years
To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivakumar Krishnasamy, MD, MMed(Surgery) principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnoea, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Sukcharanjit Singh, MD,MMed(Anaes) (0060126543142, sukcharan07@yahoo.com.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Obstructive Sleep Apnoea (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.