CancerPhase 3NCT06859190
Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer
A Phase 3 study testing estazolam 1-2 mg and Auricular pressure bean combined with electroacupuncture in people with Cancer and Insomnia, run by Qinghai Red Cross Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- estazolam 1-2 mg and Auricular pressure bean combined with electroacupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- No medications related to the treatment of insomnia have been used in the last 1 month.
- No serious dysfunction of the heart, liver, kidneys or other vital organs.
- Patients volunteered to participate in this study and signed an informed consent form.
Who cannot join
- 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.
- Have a history of severe allergies, especially to the drugs or treatments used in this study.
- History of severe mental illness with a current episode.
- History of substance abuse or alcohol dependence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China, Qinghai,Qinghai Red Cross Hospital
Xining, Qinghai, 810000
Qiuxia Dong Dr, 2816278916@qq.com
About this study
Official title: 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.
Read the 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.
- Being tested
- estazolam 1-2 mg, Auricular pressure bean combined with electroacupuncture
- Keywords
- cancer, auricular pressure beans, electroacupuncture, insomnia, estazolam
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estazolam 1-2 mgDrug
oral estazolam 1-2 mg daily at bedtime for 8 weeks.
Auricular pressure bean combined with electroacupunctureProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Arm I (ONS group) | Experimental | 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. Receives: Drug: estazolam 1-2 mg; Procedure: Auricular pressure bean combined with electroacupuncture |
| Arm II (NS group) | Active comparator | Patients will follow the standard estazolam treatment program(oral estazolam 1-2 mg daily at bedtime for 8 weeks). Receives: Drug: estazolam 1-2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinghai Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859190
- Sponsor's protocol ID
- KY-2025-03
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy of Auricular Pressure Beans Combined with Electroacupuncture and Estazolam for the Treatment of Insomnia Induced by Cancer
- ClinicalTrials.gov ID
- NCT06859190
- Acronym / sponsor ID
- KY-2025-03
- Keywords
- cancer, auricular pressure beans, electroacupuncture, insomnia, estazolam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qinghai Red Cross HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ONS group) | Experimental | Drug: estazolam 1-2 mg, Procedure: Auricular pressure bean combined with electroacupuncturePatients 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. |
| Arm II (NS group) | Active comparator | Drug: estazolam 1-2 mgPatients will follow the standard estazolam treatment program(oral estazolam 1-2 mg daily at bedtime for 8 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- No medications related to the treatment of insomnia have been used in the last 1 month.
Key exclusion criteria (7 listed)
- 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.
- Have a history of severe allergies, especially to the drugs or treatments used in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estazolam 1-2 mgoral estazolam 1-2 mg daily at bedtime for 8 weeks. | Drug | Arm I (ONS group), Arm II (NS group) |
| Auricular pressure bean combined with electroacupunctureElectroacupuncture 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. | Procedure or surgery | Arm I (ONS group) |
Primary outcome
The Insomnia Severity Index(ISI)
Time frame: 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.
3 secondary outcomes
Pittsburgh Sleep Quality Index(PSQI)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estazolam 1-2 mg and Auricular pressure bean combined with electroacupuncture in people with Cancer and Insomnia, run by Qinghai Red Cross Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Insomnia Severity Index(ISI) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.