Effect and Mechanism of Auricular Point Stimulation on Functional Dyspepsia With Sleep Disorder
NCT Number: NCT06466044
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Dyspepsia|Sleep Disorder
Interventions: BEHAVIORAL: Ear point pressure bean method in ear concha area|BEHAVIORAL: Ear point pressure bean method in earlobe
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2024-09-01
Locations: First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310006, China

Summary:
Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region, and after clinical examination, including upper gastrointestinal endoscopy, the organic diseases causing the above symptoms are excluded. According to Rome IV standard, functional dyspepsia can be divided into two categories: postprandial discomfort syndrome and epigastric pain syndrome. FD not only seriously affects the quality of life of patients, but also causes a heavy social and economic burden. Therefore, active prevention and treatment of FD, especially PDS, has become an unavoidable problem in clinic.

Epidemiological investigation shows that about 30% FD patients have many negative emotions such as sleep disorder, anxiety and depression, and many anti-negative emotional drugs themselves can cause gastrointestinal side effects, which are considered to be the key reasons for the recurrence of symptoms. In recent years, people have paid more and more attention to the brain-gut axis. Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators. In addition, the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine. However, the relationship between specific bile acids, microflora and functional dyspepsia is still uncertain.

At present, the effective and safe treatment methods for FD with sleep disorder are still very limited. In recent years, auricular point pressing bean therapy has obvious advantages in treating FD with sleep disorder. This study plans to study the clinical efficacy and mechanism of auricular point stimulation on functional dyspepsia with sleep disorder. Provide more treatment methods and ideas for clinicians, popularize and apply green diagnosis and treatment methods, bring good news to more patients, and produce remarkable economic and social benefits.

Primary Outcome Measures: 2-week response rate, Response rates were determined based on the results of the modified Functional Dyspepsia Symptom Diary questionnaire and overall treatment effect. The modified version of the modified Functional Dyspepsia Symptom Diary questionnaire was defined as the proportion of patients with a reduction of ≥5 in the modified Functional Dyspepsia Symptom Diary questionnaire after 2 weeks of treatment compared to baseline, and overall treatment effect was defined as "extremely improved" or "improved" symptoms after 2 weeks of treatment compared to baseline. When both are different, it is defined as having a therapeutic effect., 2-week
Secondary Outcome Measures: Treatment response rate, The effectiveness rate is determined based on the results of the modified Functional Dyspepsia Symptom Diary questionnaire and the overall treatment effectiveness. The modified version of the modified Functional Dyspepsia Symptom Diary questionnaire was defined as the proportion of patients with a reduction of ≥5 in the modified version of the modified Functional Dyspepsia Symptom Diary questionnaire from baseline after 8 weeks of treatment, and overall treatment effect was defined as "extremely improved" or "improved" symptoms from baseline after 8 weeks of treatment. When the two are different, it is defined as having a therapeutic effect., baseline, 1-week, 2-week, 3-week, 4-week, 5-week, 6-week, 7-week, 8-week|short form-Nepean dyspepsia Index, Clinical functional dyspepsia was assessed by the short form-Nepean dyspepsia Index scale. The short form-Nepean dyspepsia Index scale is scored using a 5-point Likert scale (1-5 points), with the lowest score of 10 points and the highest score of 50 points., baseline, 2 weeks after treatment, 8 weeks after treatment|Pittsburgh Sleep Quality Index, Clinical sleep was assessed by the Pittsburgh Sleep Quality Index. This scale is scored on a scale of 0-3, with a cumulative score of PQSI total score (0-21) and a maximum score of 21. The higher the score, the worse the quality of sleep., baseline, 2 weeks after treatment, 8 weeks after treatment|Self-rated Anxiety Scale, Clinical sleep was assessed by the Self-rated Anxiety Scal.The anxiety self-rating scale is scored on a 4-point scale, with a maximum score of 100 and a minimum score of 20. The higher the score, the more severe the anxiety symptoms. A score below 50 is normal; 50-60 is mild; A score of 70 or more is considered severe., baseline, 2 weeks after treatment, 8 weeks after treatment|Self-rated Depression Scale, Clinical sleep was assessed by the Self-rated Depression Scale. The depression self-rating scale is scored on a 4-point scale, with a maximum score of 100 and a minimum score of 20. The higher the score, the more severe the depressive symptoms. A score of 53-62 is mild depression, 63-72 is moderate depression, and a score above 72 is severe depression., baseline, 2 weeks after treatment, 8 weeks after treatment|Hyperarousal scale, Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale, baseline,2 weeks after treatment, 8 weeks after treatment|Heart rate variability, Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale, baseline,2 weeks after treatment, 8 weeks after treatment|Sleep efficiency, We will collect the sleep efficiency of patients before and after treatment by ActiGraph wGT3X-BT. \>85% indicates good sleep quality. 85% or less indicates poor sleep quality., baseline,2 weeks after treatment, 8 weeks after treatment|Total sleep time., We will collect the total sleep time of patients before and after treatment by ActiGraph wGT3X-BT. An increase in total sleep time indicates improved sleep quality., baseline,2 weeks after treatment, 8 weeks after treatment|Wake After Sleep Onset, We will collect the post-sleep awakening time of patients before and after treatment by ActiGraph wGT3X-BT. Increased waking after sleep onset suggests poorer sleep quality., baseline,2 weeks after treatment, 8 weeks after treatment|Sleep fragmentation index, We will collect the sleep fragmentation index of patients before and after treatment by ActiGraph wGT3X-BT. An increase in the sleep fragmentation index indicates poor sleep quality., baseline,2 weeks after treatment, 8 weeks after treatment
Other Outcome Measures: Changes in the composition of the intestinal microbiota., Stool samples were collected, and the changes of intestinal microbiota components before and after treatment were explored by analyzing the microbial composition, diversity index, and species composition of intestinal microbiota in feces, baseline,2 weeks after treatment, 8 weeks after treatment|Changes in Short-chain fatty acid profile composition., Blood samples were collected to analyze the changes in the quantity and concentration of short-chain fatty acids in blood, and to explore the changes in the composition of short-chain fatty acids spectrum before and after treatment, baseline,2 weeks after treatment, 8 weeks after treatment|Adverse event table, Patient safety during treatment was assessed by the Adverse Events Table, baseline,2 weeks after treatment, 8 weeks after treatment