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

Launched by QINGHAI RED CROSS HOSPITAL · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with cancer who are struggling with sleep problems, specifically insomnia. The researchers want to find out if a combination of auricular pressure beans (small beads placed on specific points of the ear), electroacupuncture (a technique that uses electrical stimulation during acupuncture), and a medication called estazolam can help improve sleep quality and reduce anxiety and depression compared to standard treatments. The trial will also keep a close eye on the safety of this combined treatment and any side effects that may occur.

To participate in this study, you need to be at least 18 years old and have been diagnosed with a type of cancer that causes insomnia, lasting for more than a month with significant sleep disturbances. You should not have taken any insomnia medications in the past month or have serious health issues with your heart, liver, or kidneys. If you join, you can expect to receive the new treatment and be monitored throughout the trial to assess its effectiveness and safety. This study is currently recruiting participants, and your involvement could help improve sleep treatments for others facing similar challenges.

Gender

ALL

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 acupuncture or auricular pressure bean therapy within the past 3 months.
• • 4. Estimated life expectancy is ≥3 months.
• • 5. Have a history of severe allergies, especially to the drugs or treatments used in this study.
• • 6. History of severe mental illness with a current episode.
• • 7. History of substance abuse or alcohol dependence.