NCT07796438Toborzás még nem indult2. fázis
Low-Frequency rTMS for In-Hospital Sleep Disturbance in Advanced NSCLC
Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for In-Hospital Sleep Disturbance in Patients With Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Sham-Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 1.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 160 (tervezett)
- Első benyújtás
- 2026. aug. 15.
- Kezdés
- 2026. aug. 31.
- Elsődleges befejezés
- 2028. jan. 1.
- Fő szponzor
- The First Affiliated Hospital of Guangzhou Medical University
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07796438
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 160
- 2026. aug. 31. és az elsődleges befejezés (2028. jan. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Initiation, discontinuation, or ≥50% dose change of sedative-hypnotic medication within 48 hours before randomization, or a planned initiation/discontinuation of medication expected to substantially affect sleep before assessment of the primary outcome.
- Planned initiation of new whole-brain or local radiotherapy, first use of high-dose corticosteroids, or switching of systemic anticancer therapy before assessment of the primary outcome.
Más betegség
- History of epilepsy or unexplained seizures, active intracranial hemorrhage, significant cerebral edema, elevated intracranial pressure, recent stroke, or severe traumatic brain injury.
- Intracranial ferromagnetic metal, cochlear implant, deep brain stimulator, cardiac pacemaker/implantable cardioverter-defibrillator, or other TMS-incompatible implant.
- Severe scalp infection, open wound, or inability to safely position the TMS coil or EEG cap.
- Pregnancy or any condition considered by the investigator to pose unacceptable risk.
- Active or uncontrolled brain metastases, or brain metastases associated with cerebral edema, hemorrhage, focal neurological symptoms, or a need for escalating corticosteroid treatment.
- Untreated or unstable obstructive sleep apnea, or another primary sleep disorder requiring priority specialist management.
- ECOG performance status ≥3, uncontrolled respiratory failure, delirium, or inability to reliably complete the prespecified sleep assessments.
Egyéb
- Unable to provide valid informed consent, unwilling to participate, or unable to reliably complete the primary RCSQ assessment.
Kiket keres a vizsgálat
- Age 18-80 years and able to understand the study and provide written informed consent.
- Pathologically or cytologically confirmed non-small cell lung cancer (NSCLC), classified according to the IASLC 9th edition TNM system as unresectable stage IIIB-IIIC, stage IVA-IVB, or recurrent disease after curative-intent treatment and considered by a multidisciplinary team to be unsuitable for further curative local therapy.
- Receiving a stable first-line or later-line systemic anticancer treatment regimen, or receiving inpatient symptom/supportive care after anticancer treatment; the treatment plan must be established before randomization, with no planned initiation of new radiotherapy or change in systemic anticancer therapy before assessment of the primary outcome.
- Mean Richards-Campbell Sleep Questionnaire (RCSQ) score <70 across two consecutive valid inpatient nights and baseline Insomnia Severity Index (ISI) score ≥8.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥3 months.
- Hospitalized for anticancer treatment-related observation, symptom control, or supportive care, with an expected remaining hospital stay of at least 10 days from randomization and ability to complete 10 stimulation sessions and the primary outcome assessment within 14 days.
- Able to complete the prespecified RCSQ assessments and brief sleep diary, continuous Lifesense HR6 monitoring, and 64-channel EEG assessment.
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