Interstitial Lung Disease and Obstructive Sleep Apnea

NCT ID: NCT05838183

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2025-12-31

Brief Summary

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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 Claudin1, Claudin2, Claudin3, Claudin4, and IL22 as biomarkers to differentiate the diagnostic efficiency of OSA in ILD, ILD+OSA, OSA, and Ctrl groups, respectively

Detailed Description

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Conditions

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ILD OSA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 relationship between imaging and ROSE and NGS

Intervention Type DIAGNOSTIC_TEST

The correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed

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 relationship between imaging and ROSE and NGS

Intervention Type DIAGNOSTIC_TEST

The correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed

Interventions

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The relationship between imaging and ROSE and NGS

The correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Association between the severity of OSA and biological specimen examination

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dan Liu

OTHER

Sponsor Role lead

Responsible Party

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Dan Liu

Master of Medicine, attending physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tianjin Medical University General Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Liu

Role: CONTACT

13920701949

Jing Feng

Role: CONTACT

13920500251

Facility Contacts

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Dan Liu

Role: primary

Jing Feng

Role: backup

Other Identifiers

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Dliu

Identifier Type: -

Identifier Source: org_study_id

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