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A study on the efficacy and mechanism of auricular point stimulation for functional dyspepsia with sleep disorders based on brain function: A single-center, randomized controlled clinical trial

A study on the efficacy and mechanism of auricular point stimulation for functional dyspepsia with sleep disorders based on brain function: A single-center, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002266
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional dyspepsia with sleep disorders

Interventions

Experimental group:Auricular concha area - ear acupressure bean
Control group:Earlobe area - Ear acupoint pressure beads

Sponsors

No. 54, Youhui Road, Shangcheng District, Hangzhou City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: A. Meets the diagnostic criteria for functional dyspepsia and sleep disorders (25, 26); B. Pittsburgh Sleep Score = 7 points; C. Right-handed, aged over 18 years; D. At least 2 weeks prior to enrollment, did not take the following medications: antibiotics (oral, intramuscular injection, and intravenous infusion), microecological preparations (probiotics, prebiotics, and synbiotics, etc.) that affect the gastrointestinal flora, any drugs or supplements that improve sleep quality or inhibit brain nerve activity, drugs or other related treatments for functional dyspepsia; E. Agrees to voluntarily participate in this study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: A. Secondary insomnia caused by medication or other diseases; B. Those with other mental disorders or severe diseases of the heart, liver, kidney and other systems; C. Those who have received this treatment before or participated in other clinical trials within the past six months; D. Those with contraindications for auricular patch application, such as skin allergy to the preparation, or damage at the contact area of the auricular patch; E. Pregnant women and lactating women; F. Those with organic brain lesions, history of brain surgery or severe trauma.

Design outcomes

Primary

MeasureTime frame
Overall treatment effect after 2 weeks of therapy;

Secondary

MeasureTime frame
Overall treatment effect after 8 weeks of therapy;Objective sleep quality monitoring;Assessment of clinical functional dyspepsia symptoms and quality of life scales;Emotional State Assessment;Autonomic nervous function assessment;Subjective sleep quality monitoring;Resting-state functional magnetic resonance imaging;Tongue appearance, pulse condition;

Countries

china

Contacts

Public ContactWUN JIANNNONG

Zhejiang Provincial Hospital of Traditional Chinese Medicine

weiyidiandian@zcmu.edu.cn13777571598

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026