Clinical Trial

Sleep Disorders and Tumor Immune Microenvironment

Recruiting
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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 \[e.g., PSQI ≥7 for insomnia\]).
Trial Details
NCT Number NCT06941948
Lead Sponsor Shanghai Zhongshan Hospital
Conditions Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer
Enrollment 400 participants
Start Date 2025-05-01
Primary Completion 2027-01-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-24