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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466044
• Other study ID #: 2024-KLS-231-02
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Contact: Wu JianNong, doctor
• Phone: 13777571598
• Email: 13777571598[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• It meets the diagnostic criteria of functional dyspepsia and sleep disorder

• 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:

• Secondary insomnia due to medication or other illness

• With other mental diseases, with serious diseases of the heart, liver, kidney and other systems

• Patients who have previously received this treatment or participated in other clinical trials within the last six months

• There are contraindications for auricular sticking, such as allergy to skin preparation and damage to the contact site of auricular sticking

• Pregnant and lactating women

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Ear point pressure bean method in ear concha area
The method of pressing beans on auricular points is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, relevant auricular points are selected, and appropriate stimulation such as kneading, pressing, pinching and pressing is given to the seeds of Vaccaria seed attached to the concha auricularis, so that the auricular points can produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.
• Ear point pressure bean method in earlobe
The auricular point pressing bean method is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, the relevant auricular points are selected, and the seeds attached to the ear lobe, which is the least innervated part of vagus nerve, are given appropriate stimulation such as kneading, pressing, pinching and pressing, so that the auricular points produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes in bile acid profile composition.	Blood samples were collected, and the changes in the number and concentration of short-chain and long-chain bile acids in the blood were analyzed to explore the changes in the composition of the bile acid spectrum before and after treatment	baseline,2 weeks after treatment, 8 weeks after treatment
Other	Adverse event table	Patient safety during treatment was assessed by the Adverse Events Table	baseline,2 weeks after treatment, 8 weeks after treatment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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