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

Analysis of the Efficacy of Auricular Pressure Beans Combined with Electroacupuncture and Estazolam for the Treatment of Insomnia Induced by Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Insomnia
• Intervention / Treatment: Drug: estazolam 1-2 mg; Procedure: Auricular pressure bean combined with electroacupuncture

Detailed Description

This study is a prospective, multicenter, randomized controlled, open-label clinical trial evaluating the efficacy of auricular pressure beans combined with electroacupuncture and estazolam in treating cancer-caused insomnia. A total of 60 patients will be enrolled and randomized into a control group and an experimental group, each consisting of 30 patients.Patients in the control group will follow the standard estazolam treatment program, with the drug dosage adjusted according to individual conditions to achieve the best therapeutic effect. In the experimental group, auricular pressure points and electroacupuncture will be skillfully integrated with estazolam treatment. The auricular pressure points will be carefully selected based on their relation to insomnia (e.g., Shenmen, heart, sympathetic) and will be replaced once or twice a week. Electroacupuncture will target key acupoints such as Baihui, Shenmen, and Sanyinjiao, with each session lasting 30 minutes and conducted twice a week.Data collection will involve the Insomnia Severity Index, Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAMA), Hamilton Depression Rating Scale (HAMD), and other assessments through questionnaires and clinical evaluations at the end of the 0th, 4th, and 8th weeks of treatment, as well as during follow-up (12th, 16th, and 20th weeks). All adverse reactions occurring throughout the treatment process will be closely monitored and recorded, including both drug-related and non-drug-related adverse reactions. Professional statistical software will be used to analyze the data rigorously, comparing dynamic changes in various indicators between the experimental and control groups before and after treatment, thereby scientifically assessing the efficacy and safety of the combined treatment for cancer-related insomnia. This rigorous study design and comprehensive data analysis aim to provide new perspectives and evidence for treating cancer-related insomnia.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Recruiting
      • China, Qinghai,Qinghai Red Cross Hospital
      • Contact: Qiuxia Dong Dr; Email: 2816278916@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (ONS group); Patients will receive estazolam with auricular pressure points and electroacupuncture treatment. Interventions:In the experimental group, estazolam (oral estazolam 1-2 mg daily at bedtime) was combined with auricular pressure point therapy and electroacupuncture over an 8-week period.	Drug: estazolam 1-2 mg; oral estazolam 1-2 mg daily at bedtime for 8 weeks.; Procedure: 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.
Active Comparator: Arm II (NS group); Patients will follow the standard estazolam treatment program(oral estazolam 1-2 mg daily at bedtime for 8 weeks).	Drug: estazolam 1-2 mg; oral estazolam 1-2 mg daily at bedtime for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).
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.	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).
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.	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).

Collaborators and Investigators

• Sponsor: Qinghai Red Cross Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cancer; insomnia; electroacupuncture; estazolam; auricular pressure beans
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents; Anticonvulsants; Estazolam
• Other Study ID Numbers: KY-2025-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No