COPDNCT03182309
Registry for Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome in China
An observational study of COPD and Sleep Apnea Syndromes, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases. It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very high. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Sleep Apnea Syndromes
- How many people
- 3,502 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive COPD patients in 10 participating centers in China
Who may be able to join
- COPD patients with informed consent
Who cannot join
- pregnant patients, patients with serious respiratory diseases other than COPD, patients with limited life expectancy, patients that can't coordinate well
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000
Ke Hu, MD, 18971035988, hukejx@163.com
About this study
Official title: The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome
COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases. It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very high. COPD and sleep apnea may have pathological or genetics interactions so that patients having both disorders tend to have worse outcomes than either condition alone. Data reflecting the prevalence, disease course and outcome of overlap syndrome is very limited in China. Therefore, the aim of the study is to describe the prevalence, treatment and outcome in Chinese patients and exploring the underlying interaction mechanism.
- Conditions
- COPD, Sleep Apnea Syndromes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD acute exacerbation
record the exacerbation events and related hospitalizations
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Prospective
- Enrolment
- 3,502 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182309
- Sponsor's protocol ID
- 2016YFC1304403
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao Z, Zhang D, Sun H, Chang D, Lv X, Lin J, Liu J, Wu X, Hu K, Guo X, Tong Z. Anxiety and depression in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Sleep Breath. 2022 Dec;26(4):1603-1611. doi: 10.1007/s11325-021-02500-2. Epub 2021 Nov 16.
PubMed 34783978Zhu J, Zhao Z, Wu B, Shi Z, Nie Q, Fu Z, Zeng Z, Hu W, Dong M, Xiong M, Hu K. Effect of Body Mass Index on Lung Function in Chinese Patients with Chronic Obstructive Pulmonary Disease: A Multicenter Cross-Sectional Study. Int J Chron Obstruct Pulmon Dis. 2020 Oct 13;15:2477-2486. doi: 10.2147/COPD.S265676. eCollection 2020.
PubMed 33116464Hu W, Dong M, Xiong M, Zhao D, Zhao Y, Wang M, Wang T, Liu Z, Lu L, Hu K. Clinical Courses and Outcomes of Patients with Chronic Obstructive Pulmonary Disease During the COVID-19 Epidemic in Hubei, China. Int J Chron Obstruct Pulmon Dis. 2020 Sep 23;15:2237-2248. doi: 10.2147/COPD.S265004. eCollection 2020.
PubMed 33061341Zhu J, Zhao Z, Nie Q, Wang Y, Fu Z, Guo X, Hu K. Effect of lung function on the apnea-hypopnea index in patients with overlap syndrome: a multicenter cross-sectional study. Sleep Breath. 2020 Sep;24(3):1059-1066. doi: 10.1007/s11325-019-01961-w. Epub 2019 Nov 25.
PubMed 31768930
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT03182309
- Acronym / sponsor ID
- 2016YFC1304403
- Conditions
- COPD, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,502 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Jun 2017 (actual)
- 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.
COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases. It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very high. COPD and sleep apnea may have pathological or genetics interactions so that patients having both disorders tend to have worse outcomes than either condition alone. Data reflecting the prevalence, disease course and outcome of overlap syndrome is very limited in China. Therefore, the aim of the study is to describe the prevalence, treatment and outcome in Chinese patients and exploring the underlying interaction mechanism.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive COPD patients in 10 participating centers in China
Key inclusion criteria (1 listed)
- COPD patients with informed consent
Key exclusion criteria (1 listed)
- pregnant patients, patients with serious respiratory diseases other than COPD, patients with limited life expectancy, patients that can't coordinate well
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
COPD acute exacerbation
Time frame: 3 years
record the exacerbation events and related hospitalizations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Derived from this study: PubMed 34783978Zhao Z, Zhang D, Sun H, Chang D, Lv X, Lin J, Liu J, Wu X, Hu K, Guo X, Tong Z. Anxiety and depression in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Sleep Breath. 2022 Dec;26(4):1603-1611. doi: 10.1007/s11325-021-02500-2. Epub 2021 Nov 16.
- Derived from this study: PubMed 33116464Zhu J, Zhao Z, Wu B, Shi Z, Nie Q, Fu Z, Zeng Z, Hu W, Dong M, Xiong M, Hu K. Effect of Body Mass Index on Lung Function in Chinese Patients with Chronic Obstructive Pulmonary Disease: A Multicenter Cross-Sectional Study. Int J Chron Obstruct Pulmon Dis. 2020 Oct 13;15:2477-2486. doi: 10.2147/COPD.S265676. eCollection 2020.
- Derived from this study: PubMed 33061341Hu W, Dong M, Xiong M, Zhao D, Zhao Y, Wang M, Wang T, Liu Z, Lu L, Hu K. Clinical Courses and Outcomes of Patients with Chronic Obstructive Pulmonary Disease During the COVID-19 Epidemic in Hubei, China. Int J Chron Obstruct Pulmon Dis. 2020 Sep 23;15:2237-2248. doi: 10.2147/COPD.S265004. eCollection 2020.
- Derived from this study: PubMed 31768930Zhu J, Zhao Z, Nie Q, Wang Y, Fu Z, Guo X, Hu K. Effect of lung function on the apnea-hypopnea index in patients with overlap syndrome: a multicenter cross-sectional study. Sleep Breath. 2020 Sep;24(3):1059-1066. doi: 10.1007/s11325-019-01961-w. Epub 2019 Nov 25.
- Individual participant dataSharing planned: Undecided
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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.
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 COPD and Sleep Apnea Syndromes, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 9 Jun 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Hu, MD (18971035988, hukejx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD acute exacerbation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182309, which also lists 4 linked publications.
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 9 Jun 2017.