Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01171196
• Lead Sponsor: The University of Hong Kong

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

a. No known history of any sleep disorder

Exclusion Criteria

1. History of heavy alcoholism ( ≥ 3 times / week)
2. Underlying pulmonary diseases
3. Recent upper respiratory tract infection in the past one week
4. Unstable medical conditions
5. Pregnancy
6. History of psychiatric illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To validate the Berlin questionnaire and STOP-BANG as effective screening tools	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 Outcome Measures

Name	Time	Method
the predictive performance on OSA of Berlin questionnaire and STOP-BANG	at the time of completing questionnaire	To compare the predictive performance on OSA of Berlin questionnaire and STOP-BANG in our Chinese population

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong Island, Hong Kong