estazolam 1-2 mgAuricular pressure bean combined with electroacupuncture
estazolam 1-2 mg: oral estazolam 1-2 mg daily at bedtime for 8 weeks.
Auricular pressure bean combined with electroacupuncture: Electroacupuncture treatment will be performed on seven acupoints, including Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), and Sanyinjiao (SP6). Each session lasts for 30 minutes and is conducted twice a week.In addition, auricular point seed-pressing therapy will be applied to bilateral auricular points related to insomnia (Shenmen, Heart, and Sympathetic). Each auricular point will be pressed for 1 minute, three times a day. The total treatment course is eight weeks.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
The Insomnia Severity Index(ISI) — Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks). The scale is a simple tool used for screening insomnia, consisting of 7 items designed to assess the nature and symptoms of sleep disturbances in the subjects.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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