Auricular acupressure for treating functional dyspepsia and insomnia
Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial
This study is testing whether auricular acupressure can help people with functional dyspepsia and insomnia feel better by improving their sleep and digestive symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06466044 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of auricular acupressure on patients suffering from functional dyspepsia and insomnia. It aims to evaluate the efficacy of this treatment by measuring changes in sleep quality, gastrointestinal symptoms, and psychological status through various assessments, including the Pittsburgh Sleep Quality Index (PSQI) and actigraphy. Additionally, the study will explore the therapeutic mechanisms involved by analyzing gut microbiota and metabolic profiles. The goal is to provide a non-pharmacological intervention for patients experiencing these conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the diagnostic criteria for functional dyspepsia and insomnia.
Not a fit: Patients with secondary insomnia due to medication or other diseases, or those with severe comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from functional dyspepsia and insomnia.
How similar studies have performed: While there is limited data on auricular acupressure specifically for these conditions, similar non-pharmacological approaches have shown promise in managing related symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * It meets the diagnostic criteria of functional dyspepsia and insomnia * Age 18 years or older * The following drugs were not taken for at least 2 weeks before enrollment: antibiotics (oral, intramuscical and intravenous), microecological preparations (probiotics, prebiotics and Biostime, etc.) and other drugs affecting the gastrointestinal flora, any drugs or health products that improve sleep quality or inhibit neural activity in the brain, drugs related to the treatment of functional dyspepsia or other related treatments * Agree to participate in the study voluntarily and sign the informed consent Exclusion Criteria: 1. Secondary insomnia caused by medication or other diseases; 2. Patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems; 3. Those who have previously received this treatment method or participated in other clinical trials within 6 months; 4. Presence of contraindications for auricular patches, such as skin hypersensitivity or damage to the application site; 5. Pregnant and lactating women.
Where this trial is running
Hangzhou, Zhejiang
- First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Wu JianNong, doctor — The First Affiliated Hospital of Zhejiang Chinese Medical University
- Study coordinator: Wu JianNong, doctor
- Email: 13777571598@163.com
- Phone: 13777571598
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.