- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05838183
Interstitial Lung Disease and Obstructive Sleep Apnea
Study on the Clinical Characteristics of Interstitial Lung Disease and Obstructive Sleep Apnea
Clinically, all patients with interstitial lung disease(ILD) were observed, and relevant clinical data were collected. Bronchoscopic specimens were collected according to the condition of the enrolled patients, and the rapid on site evaluation(ROSE) was evaluated, combined with the metagenomic next generation sequencing(mNGS) results of these patients. To observe the etiology and biological characteristics of exacerbation in patients with interstitial lung disease.
All patients undergo polysomnography (PSG) and drug-induced sleep endoscopy(DISE). The biological specimens was obtained for molecular biology or other tests.We detected ZNF331, Claudin1, Claudin2, Claudin3, Claudin4, and IL22 as biomarkers to differentiate the diagnostic efficiency of OSA in ILD, ILD+OSA, OSA, and Ctrl groups, respectively
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dan Liu
- Phone Number: 13920701949
- Email: liudan_nkdx@163.com
Study Contact Backup
- Name: Jing Feng
- Phone Number: 13920500251
- Email: jingfeng_zyy@126.com
Study Locations
-
-
-
Tianjin, China, 300000
- Recruiting
- Tianjin Medical University General Hospital
-
Contact:
- Dan Liu
- Phone Number: liudan_nkdx@163.com
- Email: liudan_nkdx@163.com
-
Contact:
- Jing Feng
- Phone Number: jingfeng_zyy@126.com
- Email: jingfeng_zyy@126.com
-
Principal Investigator:
- Dan Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- over 18 years old and under 80 years old.
- Clinical diagnosis of interstitial lung disease or obstructive respiratory sleep apnea syndrome.
- Patient is conscious and capable of signing informed consent.
- The patient may wear a polysomnograph.
Exclusion criteria:
- malignant tumors.
- severe heart failure.
- uremia.
- autoimmune diseases.
- pulmonary embolism, and end-stage chronic obstructive pulmonary disease.
- Patients with mental illnesscannot sign informed consent on their own.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ILD with OSA group
ILD patient diagnosed with OSA by PSG.
Bronchoscopy was performed to obtain alveolar lavage fluid in ILD patients and lung tissue was obtained for ROSE and mNGS in appropriate patients
|
The correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed
Other Names:
|
|
ILD without OSA
ILD patients excluded OSA through PSG.
Bronchoscopy was performed to obtain alveolar lavage fluid in ILD patients and lung tissue was obtained for ROSE and mNGS in appropriate patients
|
The correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
imaging changes and ROSE and NGS in patients
Time Frame: 2Day
|
Relationship between imaging changes and ROSE and NGS in patients with interstitial lung disease
|
2Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity and biological examination of OSA patients
Time Frame: 2Day
|
Classification of the severity of OSA and the relationship between positive results of biological or other tests
|
2Day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dliu
Drug and device information, study documents
product manufactured in and exported from the U.S.
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