OSANCT01801761
A Simplified Questionnaire to Detect OSA in COPD Patients
An observational study of OSA and COPD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: develop group : previous COPD cohort study validation group : consecutive COPD patient from outpatients clinics
Who may be able to join
- stable COPD patients
Who cannot join
- cancer exacerbation in recent 2 months pregnancy central type sleep apnea claustrophobia chronic respiratory failure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, 333
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| develop group | previous COPD study | |
| validation group | consecutive COPD patients from outpatient clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: since Dec 1, 2012 to Dec 1, 2014 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai-Yu Wang, MD, Principal investigator, Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801761
- Sponsor's protocol ID
- 101-3555b
- Status last verified
- Dec 2012
- First submitted
- 28 Dec 2012
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simplified Screening Questionnaire to Detect the Existence of Severe Obstructive Sleep Apnea in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT01801761
- Acronym / sponsor ID
- 101-3555b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| develop group | – | –previous COPD study |
| validation group | – | –consecutive COPD patients from outpatient clinics |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- develop group : previous COPD cohort study validation group : consecutive COPD patient from outpatients clinics
Key inclusion criteria (1 listed)
- stable COPD patients
Key exclusion criteria (1 listed)
- cancer exacerbation in recent 2 months pregnancy central type sleep apnea claustrophobia chronic respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The efficacy of simple questionnaire to detect severe OSA in COPD patients
Time frame: since Dec 1, 2012 to Dec 1, 2014 (up to 2 years)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsai-Yu Wang, MD principal investigator
Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA and COPD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of simple questionnaire to detect severe OSA in COPD patients (time frame: since Dec 1, 2012 to Dec 1, 2014 (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016; AzTrials last refreshed its copy on 2 Nov 2026.