NCT01171196

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

July 27, 2010

Last Update Submit

November 5, 2015

Conditions

Obstructive Sleep Apnea

Keywords

Sleep ApneaQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • the predictive performance on OSA of Berlin questionnaire and STOP-BANG

    at the time of completing questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • a. No known history of any sleep disorder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong Island, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Agnes YK Lai, MSc

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Technical Officer

Study Record Dates

First Submitted

July 27, 2010

First Posted

July 28, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

HK(1)