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Clinical Trials/NCT01171196
NCT01171196CompletedNot Applicable

Validation of Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea

The University of Hong Kong1 site in 1 country378 target enrollmentStarted: July 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
378
Locations
1
Primary Endpoint
To validate the Berlin questionnaire and STOP-BANG as effective screening tools

Study Overview

Brief Summary

The purpose of this study is to validate the Berlin questionnaire and STOP-BANG (snore, tired, obstruction, pressure, body mass index (BMI), age, neck, gender) as effective screening tools for Chinese subjects who are suspected to have obstructive sleep apnea (OSA).

Detailed Description

Obstructive sleep apnea (OSA) is a common sleep related breathing disorder associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent in both western (4-26%) and eastern countries (4-19%). In recent studies, it has been estimated that at least 70-80% of middle aged individuals with sleep apnea are undiagnosed and untreated. The prevalence of undiagnosed OSA subjects within the community suggests the need for a greater awareness and a high index of suspicion of this disease entity as well as its associated short- and long-term comorbidities.

A reliable and easy-to-use screening questionnaire is required for efficient prediction of OSA and treatment arrangement. It would be helpful to prioritize patients who require sleep study according to the probability of suffering from sleep apnea. It reduces the use of sleep study for those with low probability of having OSA, but giving treatment to those who are with more severe OSA first. Meanwhile, it enhances the cost effective management of disease especially with limited resources in our society.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • a. No known history of any sleep disorder

Exclusion Criteria

  • History of heavy alcoholism ( ≥ 3 times / week)
  • Underlying pulmonary diseases
  • Recent upper respiratory tract infection in the past one week
  • Unstable medical conditions
  • History of psychiatric illness

Outcomes

Primary Outcomes

To validate the Berlin questionnaire and STOP-BANG as effective screening tools

Time Frame: at the time of completing the questionnaire

To validate the Berlin questionnaire and STOP-BANG as effective screening tools for Chinese subjects who are suspected to have OSA

Secondary Outcomes

  • the predictive performance on OSA of Berlin questionnaire and STOP-BANG(at the time of completing questionnaire)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Agnes Yuen-Kwan Lai

Senior Technical Officer

The University of Hong Kong

Study Sites (1)

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