functional dyspepsia with sleep disorders
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Overall treatment effect after 2 weeks of therapy; | — |
Secondary
| Measure | Time 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
Zhejiang Provincial Hospital of Traditional Chinese Medicine