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临床试验/NCT07120711
NCT07120711招募中不适用

Regulatory Mechanisms of EGR2 and NLRP3 Inflammatory Pathways in Cognitive Impairment and Depressive-Anxiety-Like Behaviors Associated With Obstructive Sleep Apnea-Hypopnea Syndrome

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Expression levels of EGR2 and NLRP3 in PBMCs, saliva, and subcutaneous fat tissue

研究概览

简要总结

Obstructive sleep apnea-hypopnea syndrome (OSAS) is a common disorder in which repeated airway blockages during sleep lead to low oxygen levels, inflammation, and disrupted sleep. Many OSAS patients-both children and adults-experience problems with memory, attention, and mood, such as anxiety or depression. However, the exact molecular drivers of these brain changes are not fully understood.

This observational study will enroll:

Children (ages 2-18) and adults (>18 years) with OSAS, as well as age- and sex-matched healthy volunteers.

Clinical assessments: Children will undergo routine ENT examinations (including nasal endoscopy and X-rays); adults will have an overnight sleep study (polysomnography). All participants will complete questionnaires on sleepiness (e.g., ESS), mood (PHQ-9, GAD-7), and cognitive screening (MoCA for adults, age-appropriate scales for children).

Sample collection: A small blood draw (3 mL) and, when applicable (e.g., adults undergoing surgery), a tiny subcutaneous fat biopsy. Saliva samples will also be collected.

Laboratory tests:

Measure expression levels of two key inflammatory pathway genes-EGR2 and NLRP3-in blood cells, saliva, and fat tissue using RNA sequencing, RT-qPCR, and Western Blot.

Correlate these molecular markers with sleep parameters (AHI, oximetry), cognitive scores, and mood scores.

Data analysis: Develop and validate machine-learning models that integrate data from multiple tissues to predict who is at highest risk for cognitive or mood disturbances.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-18 years with obstructive snoring or sleep apnea features on initial ENT outpatient screening.
  • Adults (>18 years) with suspected OSAS in a sleep or respiratory clinic, presenting with chronic snoring, witnessed apneas, or daytime sleepiness, and without severe chronic heart, liver, kidney failure, psychiatric disorders, or pregnancy.
  • Signed written informed consent by the participant or their legal guardian. Not currently enrolled in any other registered clinical trial.

排除标准

  • Presence of congenital craniofacial malformations. Severe heart, lung, liver, or kidney failure, or major neurological disease. Recent use of anti-inflammatory or other immunomodulatory medications. Current psychiatric disorder or pregnancy

结局指标

主要结局

Expression levels of EGR2 and NLRP3 in PBMCs, saliva, and subcutaneous fat tissue

时间窗: Jul 2025 - Sep 2026

Quantitative measurement of EGR2 and NLRP3 mRNA (by RNA-seq and RT-qPCR) and protein levels (by Western blot and ELISA) in peripheral blood mononuclear cells, saliva, and (when available) subcutaneous fat tissue collected at baseline. These molecular markers will be correlated with cognitive (MoCA) and mood (PHQ-9, GAD-7) scores

次要结局

  • Multi-omics association of molecular markers with clinical phenotypes(Jul 2025 - Sep 2026)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lai Jiang

021-25077820

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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