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NCT Number: NCT06466044

Effect and Mechanism of Auricular Acupressure on Functional Dyspepsia With Insomnia

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 insomnia, 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 insomnia are still very limited. In recent years, Auricular Acupressure has obvious advantages in treating FD with insomnia. This study plans to study the clinical efficacy and mechanism of Auricular Acupressure on functional dyspepsia with insomnia. 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

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Key information

Conditions

Functional Dyspepsia Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

About this study

  • The effective rate. The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline
  • PSQI score. The PSQI is a widely used questionnaire to assess one's sleep quality for the past month, with 7 components for 7 specific features of sleep.
  • sleep quality assessed by actigraphy: Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT.
  • modified FDSD
  • SF-NDI: Evaluate the functional dyspepsia of patients with functional dyspepsia and insomnia by SF-NDI.
  • SAS, SDS: SAS and SDS were used to evaluate the patients' psychological status.
  • HAS, HRV: Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability.
  • To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics.
  • The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
  • Averse events. Any adverse events, such as unfavorable or unintended signs, symptoms, or diseases, related to the AA treatment or the administration of these comorbidity was reported by patients and professional nurses. Severe adverse events had to be reported to the principal investigator and the data and safety monitoring board within 24 hours after their occurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • It meets the diagnostic criteria of functional dyspepsia and insomnia
  • 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 caused by medication or other diseases;
  • Patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems;
  • Those who have previously received this treatment method or participated in other clinical trials within 6 months;
  • Presence of contraindications for auricular patches, such as skin hypersensitivity or damage to the application site;
  • Pregnant and lactating women.

Treatment and study plan

Auricular acupressure in concha area

Behavioral

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.

Auricular acupressure in earlobe

Behavioral

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.

Primary outcomes

  1. the effective rate at week 2

    Time frame: 2-week

    The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline PSQI score

Secondary outcomes

  1. the effective rate at week 8

    Time frame: 8-week after treatment

    The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 8 weeks as compared with the baseline PSQI score

  2. short form-Nepean dyspepsia Index

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  3. Pittsburgh Sleep Quality Index

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  4. Self-rated Anxiety Scale

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  5. Self-rated Depression Scale

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  6. Hyperarousal scale

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale

  7. Heart rate variability

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale

  8. Sleep efficiency

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  9. Total sleep time.

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  10. Wake After Sleep Onset

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  11. Sleep fragmentation index

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    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.

  12. OTE

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    To assess patient satisfaction with treatment of functional dyspepsia

  13. modified FDSD,

    Time frame: baseline, 2 weeks, 8 weeks after treatment

    The patient was evaluated for symptoms of functional dyspepsia

Other outcomes

  1. Changes in the composition of the intestinal microbiota.

    Time frame: baseline,2 weeks after treatment, 8 weeks after treatment

    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

  2. Changes in Short-chain fatty acid profile composition.

    Time frame: baseline,2 weeks after treatment, 8 weeks after treatment

    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

  3. Adverse event table

    Time frame: baseline,2 weeks after treatment, 8 weeks after treatment

    Patient safety during treatment was assessed by the Adverse Events Table

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 20, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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