About this trial
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
This trial accepts healthy volunteersQualifiers
Age 18 and above.
The diagnosis of a malignant solid tumor was confirmed by pathological examination.
Clinically diagnosed cancer-caused insomnia with insomnia symptoms lasting more than 1 month, more than 3 or more times per week.
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.
Disqualifiers
Irregular sleep-wake cycles in jobs with shift demands or due to inconsistent work schedules.
Inadequately treated for another sleep disorder (e.g., sleep disorder disorders such as sleep apnea obstruction syndrome, restless leg syndrome, etc.).
Received acupuncture or auricular pressure bean therapy within the past 3 months.
Estimated life expectancy is ≥3 months.
Trial design
Parallel
Treatments tested in this trial
estazolam 1-2 mg
Drugoral estazolam 1-2 mg daily at bedtime for 8 weeks.
Auricular pressure bean combined with electroacupuncture
Procedure/SurgeryElectroacupuncture 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.
Treatment groups
Trial outcomes
Primary outcomes
The Insomnia Severity Index(ISI)
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.
Secondary outcomes
Pittsburgh Sleep Quality Index(PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is used to assess the sleep quality of subjects over the past month . It consists of 9 self-rated items and 5 other-rated items, with a total of 18 items grouped into 7 factors. Each factor is scored on a scale of 0 to 3, and the cumulative scores of the factor components make up the total score of the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Hamilton Anxiety Scale(HAMA)
The Hamilton Anxiety Scale (HAMA) includes 14 items and is one of the most widely used clinician-administered scales in psychiatry. It is primarily used to assess the severity of anxiety symptoms in patients with neuroses and other conditions.
Hamilton Depression Rating Scale(HAMD)
The scale includes 24 items and is primarily scored through the clinician's observation and questioning of the patient, aiming to provide a comprehensive assessment of various aspects of depression.
Sponsors and contacts
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