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NCT Number: NCT05838183

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Association between the severity of OSA and biological specimen examination

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Liu

CONTACT

[email protected]

13920701949

Jing Feng

CONTACT

[email protected]

13920500251

Sponsors and collaborators

Lead sponsor

Dan Liu

Other

Registry information

Official study title

Study on the Clinical Characteristics of Interstitial Lung Disease and Obstructive Sleep Apnea

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.