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Low-Frequency rTMS for In-Hospital Sleep Disturbance in Advanced NSCLC

NCT07796438 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-09-01

No results posted yet for this study

Summary

This randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adults with advanced non-small cell lung cancer (NSCLC) and clinically significant in-hospital sleep disturbance.

A total of 160 participants with unresectable stage IIIB-IIIC or stage IV NSCLC, or recurrent NSCLC not suitable for curative local treatment, will be randomly assigned in a 1:1 ratio to active rTMS or matched sham stimulation. Active rTMS will target the left dorsolateral prefrontal cortex and will be delivered once daily for 10 sessions completed within 10-14 days.

The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the nights following stimulation sessions 8, 9, and 10. The study will also evaluate wearable-device sleep measures, insomnia symptoms, pain and symptom burden, psychological symptoms, quality of life, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Sleep Wake Disorders

Interventions

DEVICE

Active Low-Frequency Repetitive Transcranial Magnetic Stimulation

Active rTMS will be delivered over the left dorsolateral prefrontal cortex at the F3 position using a figure-of-eight coil. Stimulation parameters are 1 Hz, 100% of the resting motor threshold, and 1,800 pulses per session over approximately 30 minutes. Treatment will be administered once daily for a total of 10 sessions completed within 10-14 days. No more than one study stimulation session will be administered on the same calendar day. Study stimulation will not be performed during intravenous anticancer drug infusion, blood transfusion, sedated bronchoscopy, or clinically significant infusion reactions.

DEVICE

Sham Repetitive Transcranial Magnetic Stimulation

Sham stimulation will be administered using a dedicated sham coil or validated active/sham masking module compatible with the study device. Target location, participant positioning, stimulation rhythm, sound, session duration, and interaction procedures will match active rTMS, but the sham procedure will not produce the intended therapeutic cortical stimulation. Sham stimulation will be administered once daily for a total of 10 sessions completed within 10-14 days.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-01-01
Completion
2028-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796438 on ClinicalTrials.gov