NCT01829854

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

1.5 years

First QC Date

April 9, 2013

Last Update Submit

April 10, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Obstructive Sleep Apnoea

    To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery .

    2 years

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 .

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sivakumar Krishnasamy, MD, MMed(Surgery)

    University of Malaya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Sukcharanjit Singh, MD,MMed(Anaes)

CONTACT

Dr Sivakumar Krishnasamy, MBBS,MMed(Surgery)

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations