跳至主要内容
临床试验/NCT05838183
NCT05838183招募中不适用

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

Dan Liu1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
imaging changes and ROSE and NGS in patients

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • malignant tumors.
  • severe heart failure.
  • autoimmune diseases.
  • pulmonary embolism, and end-stage chronic obstructive pulmonary disease.
  • Patients with mental illnesscannot sign informed consent on their own.

研究组 & 干预措施

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

干预措施: The relationship between imaging and ROSE and NGS (Diagnostic Test)

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

干预措施: The relationship between imaging and ROSE and NGS (Diagnostic Test)

结局指标

主要结局

imaging changes and ROSE and NGS in patients

时间窗: 2Day

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

次要结局

  • Severity and biological examination of OSA patients(2Day)

研究者

发起方
Dan Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dan Liu

Master of Medicine, attending physician

Tianjin Medical University General Hospital

研究点 (1)

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