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Clinical Trials in China / NCT06941948
Recruiting Observational

Sleep Disorders and Tumor Immune Microenvironment

NCT06941948 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Observational
Started
2025-05-01
Last updated
2025-04-24

Condition(s) studied

Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer

Investigational drug(s) / intervention(s)

PSQI

PSQI: PSQI

Study summary

Title: Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer: A Prospective Cohort Study

Objective:

This prospective study aims to investigate the causal relationship between sleep disorders (e.g., insomnia, obstructive sleep apnea \[OSA\]) and alterations in the tumor immune microenvironment (TIME) in lung cancer patients, and to evaluate their joint effects on immunotherapy response and long-term prognosis.

Study Design:

Prospective observational cohort study with 3-year follow-up. Participants: Newly diagnosed primary lung cancer patients (NSCLC/SCLC) prior to treatment initiation (n = 400, target sample size\*).

Exposure Groups: Stratified by sleep disorder status (confirmed via polysomnography \[OSA\] and validated questionnaires \[e.g., PSQI ≥7 for insomnia\]).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy) Exclusion Criteria: * Patients with severe mental illness, other malignant tumors, or receiving sleep medication

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhong Shan hospital Shanghai China Recruiting

More Shanghai Zhongshan Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06941948 on ClinicalTrials.gov ↗ ← All trials in China