Combining auricular pressure beans, electroacupuncture, and estazolam for treating cancer-related insomnia
Analysis of the Efficacy of Auricular Pressure Beans Combined with Electroacupuncture and Estazolam for the Treatment of Insomnia Induced by Cancer
This study is testing whether a new treatment combining auricular pressure beans, electroacupuncture, and estazolam can help cancer patients with insomnia sleep better and feel less anxious or depressed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qinghai Red Cross Hospital Academic / other |
| Locations | 1 site (Xining, Qinghai) |
| Trial ID | NCT06859190 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination therapy involving auricular pressure beans, electroacupuncture, and estazolam for patients suffering from insomnia due to cancer. It is a multicenter, randomized controlled trial that will enroll 60 patients, dividing them into a control group receiving standard estazolam treatment and an experimental group receiving the combined therapy. The study will assess improvements in sleep quality, anxiety, and depression through various validated scales over an 8-week treatment period, with follow-ups extending to 20 weeks. Safety and adverse reactions will also be closely monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of cancer and insomnia symptoms lasting over one month.
Not a fit: Patients with irregular sleep-wake cycles or other untreated sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall well-being for cancer patients experiencing insomnia.
How similar studies have performed: While the combination of these specific treatments is novel, similar approaches using acupuncture for insomnia have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xining, Qinghai
- China, Qinghai,Qinghai Red Cross Hospital — Xining, Qinghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.