Sleep disorder
Conditions
Interventions
Single arm group:Transcranial electrical stimulation (CES) is delivered using the Xiangyu Microcurrent Therapy Device RH-WDL-I, with microcurrent output of 200–300 µA applied via earlobe electrodes, o
Sponsors
The First Affiliated Hospital of Henan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old, gender not limited; 2. Patients with histologically or cytologically confirmed malignant tumors, tumor type not limited; 3. Meeting the diagnostic criteria for insomnia specified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 4. Clear consciousness, capable of cooperating with the completion of scale assessments and treatment; 5. ECOG performance status score 0–2, with expected survival time >=6 months.
Exclusion criteria
Exclusion criteria: 1. Contraindications for CES: History of epilepsy, intracranial metal implants, severe arrhythmia, skin damage or infection at the treatment site; 2. Other primary sleep disorders (e.g., restless legs syndrome, narcolepsy); 3. Patients with intracranial tumors; 4. History of severe mental illness (e.g., schizophrenia, bipolar disorder); 5. Long-term, regular use of sedative-hypnotic drugs; 6. Complicated with severe or unstable cardiac, hepatic, or renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The extent of improvement in multidimensional objective parameters of insomnia in cancer patients with CES therapy, including objective sleep efficiency (SE), total sleep time (TST) from polysomnography (PSG), and sleep duration and efficiency recorded by actigraphy.;Serum biomarkers (cortisol, IL-1ß, IL-6, SOD, MDA), anxiety and depressive symptoms (assessed by PHQ-9 and GAD-7 scales), and quality of life (assessed by EORTC QLQ-C30 scale).; | — |
Countries
China
Contacts
Public ContactKang Xiaohong
The First Affiliated Hospital of Henan Medical University
Outcome results
None listed