Effect and Mechanism of Auricular Point Stimulation on Functional Dyspepsia With Sleep Disorder

Sleep Disorder Clinical Trial

Official title: Effect and Mechanism of Auricular Point Stimulation on Functional Dyspepsia With Sleep Disorder：a Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

1. Determine the response rate based on the improved FDSD questionnaire and the results of the overall treatment effect. The modified FDSD questionnaire is defined as the proportion of patients whose improved FDSD is reduced by ≥5 after 2 weeks of treatment compared with baseline, and OTE is defined as "extremely improved" and "improved" symptoms after 2 weeks of treatment compared with baseline. When there are differences between the two, it is defined as having therapeutic effect.

2. Treatment response rate at 8 weeks

3. Evaluate the functional dyspepsia of patients with functional dyspepsia and sleep disorder by 10 items of Nipin dyspepsia index.

4. The Pittsburgh Sleep Quality Index, Insomnia Severity Index Questionnaire and Self-assessment Anxiety Scale were used to evaluate the patients' clinical sleep and psychological status.

5. Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT.

6. Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability.

7. To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and serum bile acid spectrum metabonomics.

8. The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter ;

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT06466044
• Study type: Interventional
• Source: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Contact: Wu JianNong, doctor
• Phone: 13777571598
• Email: 13777571598@163.com
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Completion date: September 1, 2024