NCT06975384

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,270 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.

Detailed description

This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 5 cohorts * Cohort 1: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of ICIs in advanced NSCLC. * Cohort 2: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC. * Cohort 3: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC. * Cohort 4: A prospective, observational cohort study to explore the association of sleep disturbance with postoperative recurrence and prognosis in early-stage NSCLC receiving radical surgery. * Cohort 5: A prospective observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of targeted therapy in advanced NSCLC.

Conditions

• Lung Cancer
• Sleep Disturbance
• Immune Checkpoint Inhibitors
• Cancer, Treatment-Related

Interventions

Type	Name	Description
OTHER	Exposure: sleep disturbance status	The assessment of sleep disturbance was conducted using Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Patients with a PSQI score \> 5 or an ISI score \> 7 were categorized as sleep disturbance patients. The assessment of chronotype was conducted using reduced Morningness-Eveningness Questionnaire (rMEQ). Patients with an rMEQ score 18-25 were categorized as the morning type, those with an rMEQ score 12-17 as the intermediate type, and those with an rMEQ score 4-11 as the evening type.

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: China