Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171196
• Other study ID #: HKCTC-1117
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: November 5, 2015
• Start date: July 2010
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong Island

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the Berlin questionnaire and STOP-BANG as effective screening tools	To validate the Berlin questionnaire and STOP-BANG as effective screening tools for Chinese subjects who are suspected to have OSA	at the time of completing the questionnaire	No
Secondary	the predictive performance on OSA of Berlin questionnaire and STOP-BANG	To compare the predictive performance on OSA of Berlin questionnaire and STOP-BANG in our Chinese population	at the time of completing questionnaire	No