NCT02127099

Brief Summary

Obstructive sleep apnoea (OSA) is a condition in which a person's sleep is disrupted with momentary periods of apnoea and hypopnoea. This occurs when there is a blockage to airflow. When this happens, the patient will snore, gasp or choke in the attempt to attain more oxygen. This results in disrupted sleep and the patient may even awake from sleep. It has been found that a great proportion of Malaysians have habitual snoring and with the increase in obesity over the years, it is a concern that OSA may be prevalent in Malaysia. However, it has been seen that OSA is commonly undiagnosed in patient. This poses a worry because these people can come in for surgery. Diagnosis of OSA before surgery is important in order to prepare for the complication related to OSA.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

April 25, 2014

Last Update Submit

May 6, 2014

Conditions

Keywords

OSAobstructivesleepapneaoperation

Outcome Measures

Primary Outcomes (1)

  • Incidence of OSA

    Incidence of OSA in surgical patients among the ethnic races.

    30 days

Secondary Outcomes (1)

  • Post-operative complications

    30 days

Study Arms (2)

Patients with OSA

Post operative patients with OSA

Post-operative Patients without OSA

All post operative patients without OSA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over age 18 undergoing non-cardiac surgery

You may qualify if:

  • adult males and females
  • age ≥ 18 years
  • undergoing elective surgery ( general,regional or local anaesthesia with monitored anaesthesia care)

You may not qualify if:

  • previous diagnosis of OSA or any sleep-related breathing disorder
  • they are unwilling
  • their surgery included tonsillectomy, septoplasty, uvloplasty, pharyngoplasty, tracheostomy, or prolonged mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveApnea

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chew Yin Wang, MBChB

    University of Malaya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chew Yin Wang, MBChB

CONTACT

Hou Yee Lai, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 30, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations