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

About this trial

Last updated a year ago

Study ID

KY-2025-03

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

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.