Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Lai Yuen Kwan Agnes, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01171196
First received: July 27, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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).


Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • To validate the Berlin questionnaire and STOP-BANG as effective screening tools [ Time Frame: at the time of completing the questionnaire ] [ Designated as safety issue: No ]
    To validate the Berlin questionnaire and STOP-BANG as effective screening tools for Chinese subjects who are suspected to have OSA


Secondary Outcome Measures:
  • the predictive performance on OSA of Berlin questionnaire and STOP-BANG [ Time Frame: at the time of completing questionnaire ] [ Designated as safety issue: No ]
    To compare the predictive performance on OSA of Berlin questionnaire and STOP-BANG in our Chinese population


Estimated Enrollment: 254
Study Start Date: July 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who are referred to have a diagnostic polysomnography (PSG) will be recruited from the Sleep Disorders Centre, Department of Medicine, Queen Mary Hospital.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171196

Contacts
Contact: Agnes YK Lai, MSc 852-2255-5886 agneslai@hku.hk
Contact: Mary SM Ip, MD 852-2255-4455 msmip@hku.hk

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong Island, Hong Kong
Contact: Agnes YK Lai, MSc    852-2255-5886    agneslai@hku.hk   
Contact: Mary MS Ip, MD    852-2255-4455    msmip@hku.hk   
Principal Investigator: Agnes y Lai, MSc         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Agnes YK Lai, MSc The University of Hong Kong
  More Information

No publications provided

Responsible Party: Lai Yuen Kwan Agnes, Senior Technical Officer, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01171196     History of Changes
Other Study ID Numbers: HKCTC-1117
Study First Received: July 27, 2010
Last Updated: October 18, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Sleep Apnea
Questionnaire

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014