NCT06953492

Brief Summary

Lung cancer remains the leading cause of cancer-related mortality globally, with tumor progression closely linked to the immune microenvironment. Sleep disorders (e.g., insomnia, obstructive sleep apnea \[OSA\]) affect 40-50% of lung cancer patients and may promote tumorigenesis via chronic inflammation, immune suppression, and metabolic dysregulation. Preclinical and epidemiological studies suggest that chronic sleep deprivation reduces NK cell activity, elevates pro-inflammatory cytokines (IL-6, TNF-α), and upregulates angiogenic factors (VEGF), though clinical evidence remains scarce. This study aims to: Evaluate associations between sleep disorders and immunosuppressive phenotypes (e.g., PD-L1 expression, T-cell exhaustion) in lung cancer patients. Analyze the impact of sleep disturbances on immunotherapy efficacy (e.g., PD-1 inhibitors) and prognostic outcomes. Explore underlying mechanisms, including hypoxia-inducible factor (HIF-1α) signaling and sympathetic nervous system activation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

7 years

First QC Date

April 16, 2025

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • OS

    Overall survival (OS) : time from immunotherapy initiation to all-cause death

    Baseline

Study Arms (1)

Lung cancer

lung cancer-Non SD; lung cancer-SD

Other: PSQI

Interventions

PSQIOTHER

PSQI

Lung cancer

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1\. Data source and time range Data source: Adult patients (≥18 years old) diagnosed with primary lung cancer (confirmed by histopathology) in \[Zhong Shan Hospital\] from January 2018 to January 2025 were retrospectively enrolled. Data extraction: Clinical, pathological and follow-up data were collected through the electronic medical record system (EMR) and the hospital cancer registry database.

You may qualify if:

  • NSCLC or SCLC was diagnosed.
  • Patients have received immunotherapy (e.g., PD-1/PD-L1 inhibitors) or standard treatment (chemotherapy/radiotherapy).
  • Sleep disorder diagnoses and immune-related biomarkers fully recorded in medical records.

You may not qualify if:

  • The patient had a history of other malignant tumors.
  • Key clinical data lacking.
  • The presence of a serious psychiatric or neurologic condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhong Shan hospital

Shanghai, China

Location

MeSH Terms

Conditions

Adenocarcinoma of LungSleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteChronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 1, 2025

Study Start

January 1, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations