NCT01801761

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

December 1, 2012

Enrollment Period

3.9 years

First QC Date

December 28, 2012

Last Update Submit

November 28, 2016

Conditions

OSACOPD

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

develop group

previous COPD study

validation group

consecutive COPD patients from outpatient clinics

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • stable COPD patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, 333, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tsai-Yu Wang, MD

    Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2012

First Posted

March 1, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 29, 2016

Record last verified: 2012-12

Locations

TW(1)