A Simplified Questionnaire to Detect OSA in COPD Patients

A Simplified Screening Questionnaire to Detect the Existence of Severe Obstructive Sleep Apnea in Chronic Obstructive Pulmonary Disease Patients

To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.

Study Overview

• Status: Completed
• Conditions: OSA; COPD

Detailed Description

To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.

With patient's BMI, neck and waist circumference, snores, witnessed apnea...

Time frame suspect to enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 333
    • Department of Thoracic Medicine, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

develop group : previous COPD cohort study validation group : consecutive COPD patient from outpatients clinics

Description

Inclusion Criteria:

• stable COPD patients

Exclusion Criteria:

• cancer exacerbation in recent 2 months pregnancy central type sleep apnea claustrophobia chronic respiratory failure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
develop group; previous COPD study
validation group; consecutive COPD patients from outpatient clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of simple questionnaire to detect severe OSA in COPD patients	The main outcome of this study : calculate the sensitivity, specificity, positive predictive value, negative predictive value, ROC curve Time frame: enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients PSG is standard diagnostic tool and it is no safety issue in this study	since Dec 1, 2012 to Dec 1, 2014 (up to 2 years)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 101-3555b