Obstructive Sleep ApneaNCT02127099
The Incidence of Undiagnosed OSA Compared in Multi-ethic Races of Malaysia & the Associated Postoperative Complications
An observational study of Obstructive Sleep Apnea, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 1,000 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2014to Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients over age 18 undergoing non-cardiac surgery
Who may be able to join
- adult males and females
- age ≥ 18 years
- undergoing elective surgery ( general,regional or local anaesthesia with monitored anaesthesia care)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
Hou Yee Lai, MBBS
Tawadod HA Abdalla, MBBS
About this study
Official title: The Incidence of Undiagnosed OSA in Multi-ethic Races of Malaysia and the Associated Postoperative Complications
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.
Read the detailed description
Research staff will interview and examine patients and review their charts to obtain information on patient characteristics. Patients will also be assessed using STOP-BANG Questionnaire \& Epworth Sleepiness Scale.
Anaesthesia and surgery will be performed according to routine standard of care.
Drugs used during anaesthesia, postoperative analgesia and hemodynamic data will be recorded.
During their stay in hospital, patients will be followed daily, and outcomes will be recorded, until discharge. Data on medications will be recorded.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, obstructive, sleep, apnea, operation
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with OSA | Post operative patients with OSA | |
| Post-operative Patients without OSA | All post operative patients without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of OSA
Incidence of OSA in surgical patients among the ethnic races.
Measured: 30 days
Secondary outcomes (1)
Post-operative complications
Any cardiovascular or respiratory complications detected during the post-operative period.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Chew Yin, University of Malaya
- Investigators
- Chew Yin Wang, MBChB, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127099
- Sponsor's protocol ID
- 1017.8
- Status last verified
- May 2014
- First submitted
- 25 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Undiagnosed OSA in Multi-ethic Races of Malaysia and the Associated Postoperative Complications
- ClinicalTrials.gov ID
- NCT02127099
- Acronym / sponsor ID
- 1017.8
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, obstructive, sleep, apnea, operation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Apr 2014 (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.
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.
Detailed description
Research staff will interview and examine patients and review their charts to obtain information on patient characteristics. Patients will also be assessed using STOP-BANG Questionnaire \& Epworth Sleepiness Scale.
Anaesthesia and surgery will be performed according to routine standard of care.
Drugs used during anaesthesia, postoperative analgesia and hemodynamic data will be recorded.
During their stay in hospital, patients will be followed daily, and outcomes will be recorded, until discharge. Data on medications will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with OSA | – | –Post operative patients with OSA |
| Post-operative Patients without OSA | – | –All post operative patients without OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over age 18 undergoing non-cardiac surgery
Key inclusion criteria (3 listed)
- adult males and females
- age ≥ 18 years
- undergoing elective surgery ( general,regional or local anaesthesia with monitored anaesthesia care)
Key exclusion criteria (3 listed)
- 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
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 OSA
Time frame: 30 days
Incidence of OSA in surgical patients among the ethnic races.
1 secondary outcome
Post-operative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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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.
Chew Yin Wang, MBChB 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 Apnea, 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 3 inclusion and 3 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 7 May 2014. 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 Chew Yin Wang, MBChB (60192340232, wangcy1836@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of OSA (time frame: 30 days). 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 7 May 2014.