A Simplified Questionnaire to Detect OSA in COPD Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801761
• Other study ID #: 101-3555b
• Status: Completed
• Phase: N/A
• First received: December 28, 2012
• Last updated: November 28, 2016
• Start date: December 2012
• Est. completion date: November 2016

Study information

• Verified date: December 2012
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• stable COPD patients

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• COPD
• OSA

Locations

Country	Name	City	State
Taiwan	Department of Thoracic Medicine, Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No