Sleep Disorders and Tumor Immune Microenvironment

Recruiting now

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

In brief

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 \[e.g., PSQI ≥7 for insomnia\]).

Key facts

Study ID

NCT06941948

Run by

Shanghai Zhongshan Hospital

People needed

400

Starts

2025-05-01

Expected to finish

2028-01-01

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy)

You may not qualify if…

• Patients with severe mental illness, other malignant tumors, or receiving sleep medication

Where it is running

• Zhong Shan hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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