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Registry for Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome in China

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ClinicalTrials.gov Identifier: NCT03182309
Recruitment Status : Unknown
Verified June 2017 by Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Recruiting
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease
COPD Sleep Apnea Syndromes

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3502 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. COPD acute exacerbation [ Time Frame: 3 years ]
    record the exacerbation events and related hospitalizations


Biospecimen Retention:   Samples With DNA
Serum and blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive COPD patients in 10 participating centers in China
Criteria

Inclusion Criteria:

  • COPD patients with informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182309


Contacts
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Contact: Ke Hu, MD 18971035988 hukejx@163.com

Locations
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China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430000
Contact: Ke Hu, MD    18971035988    hukejx@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03182309    
Other Study ID Numbers: 2016YFC1304403
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases