NCT03182309

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

June 7, 2017

Last Update Submit

June 7, 2017

Conditions

COPDSleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

  • COPD acute exacerbation

    record the exacerbation events and related hospitalizations

    3 years

Eligibility Criteria

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

Consecutive COPD patients in 10 participating centers in China

You may qualify if:

  • COPD patients with informed consent

You may not qualify if:

  • pregnant patients, patients with serious respiratory diseases other than COPD, patients with limited life expectancy, patients that can't coordinate well

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 34783978DERIVED

  • Zhu 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.

    PMID: 33116464DERIVED

  • Hu 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.

    PMID: 33061341DERIVED

  • Zhu 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.

    PMID: 31768930DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and blood cells

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Ke Hu, MD

CONTACT

18971035988hukejx@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pulmonary Vascular Disease Center

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 9, 2017

Study Start

June 15, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

CN(1)