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Recruiting Phase 3 NCT06859190

Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer

Trial Parameters

Condition Cancer
Sponsor Qinghai Red Cross Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-01
Completion 2026-03-01
All Conditions
Interventions
estazolam 1-2 mgAuricular pressure bean combined with electroacupuncture

Brief Summary

The core objectives of this study are to assess the short-term and long-term efficacy of auricular acupoint pressure beans combined with electroacupuncture and estazolam in the treatment of cancer-caused insomnia. The study aims to accurately compare the differences between this combination therapy and standard Western medicine in improving sleep quality and effectively alleviating anxiety and depression. Additionally, it will meticulously observe the safety of the combined treatment and record the occurrence and potential causative factors of any adverse reactions.

Eligibility Criteria

Inclusion Criteria: 1. Age 18 and above. 2. The diagnosis of a malignant solid tumor was confirmed by pathological examination. 3. Clinically diagnosed cancer-caused insomnia with insomnia symptoms lasting more than 1 month, more than 3 or more times per week. 4. An Insomnia Severity Index (ISI) score of 8 or higher and meets the criteria for insomnia disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. 5. No medications related to the treatment of insomnia have been used in the last 1 month. 6. No serious dysfunction of the heart, liver, kidneys or other vital organs. 7. Patients volunteered to participate in this study and signed an informed consent form. Exclusion Criteria: 1. Irregular sleep-wake cycles in jobs with shift demands or due to inconsistent work schedules. 2. Inadequately treated for another sleep disorder (e.g., sleep disorder disorders such as sleep apnea obstruction syndrome, restless leg syndrome, etc.). 3. Received acupunct

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