Interstitial Lung Disease and Obstructive Sleep Apnea

NCT05838183 | Recruiting

• 1 other identifier: Dliu
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ILD OSA

Outcome Measures

Primary Outcomes (1)

• imaging changes and ROSE and NGS in patients

  Relationship between imaging changes and ROSE and NGS in patients with interstitial lung disease

  2Day

Secondary Outcomes (1)

• Severity and biological examination of OSA patients

  2Day

Study Arms (2)

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

Diagnostic Test: The relationship between imaging and ROSE and NGS

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

Diagnostic Test: The relationship between imaging and ROSE and NGS

Interventions

The relationship between imaging and ROSE and NGS DIAGNOSTIC_TEST

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

Also known as: Association between the severity of OSA and biological specimen examination

ILD with OSA group; ILD without OSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Interstitial lung disease and respiratory sleep apnoea

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dan Liu: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Alveolar lavage fluid、Lung tissue、Blood samples or other samples

Central Study Contacts

Dan Liu

CONTACT

13920701949; liudan_nkdx@163.com

Jing Feng

CONTACT

13920500251; jingfeng_zyy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of Medicine, attending physician

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 1, 2023
• Study Start: September 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (1)