Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 8:31 AM
Study NCT ID:
NCT07442734
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms
Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Organization:
Study Overview
Official Title:
Study on the Efficacy and Mechanism of Auricular Stimulation for Functional Dyspepsia With Insomnia Based on Brain Function: A Single-center, Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional dyspepsia (FD) is a chronic disorder of gut-brain interaction characterized by bothersome upper abdominal symptoms arising from the gastroduodenal region. Diagnosis is made after clinical evaluation has excluded structural disease that could explain symptoms (e.g., upper gastrointestinal endoscopy). According to Rome IV criteria, FD is categorized into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), with symptom overlap commonly observed. FD is prevalent worldwide and is associated with substantial impairment in health-related quality of life and a significant socioeconomic burden.
Sleep disturbance, anxiety, and depression are frequent in FD and are associated with symptom severity and recurrence. Current management-such as prokinetic agents, acid-suppressive therapy, and psychotropic medications when indicated-can be limited by variable efficacy, adverse effects, and concerns regarding long-term use. The pathophysiology of FD is multifactorial and incompletely understood; increasing evidence highlights dysregulation of the brain-gut axis and autonomic nervous system function (12,13). Auricular vagus nerve-related stimulation may influence brainstem neurotransmission, gastric tone/motility, and mood (14), suggesting a potentially safe, non-pharmacological approach for FD with comorbid sleep problems. However, the mechanistic links among autonomic regulation, gut microbiota/short-chain fatty acids, and FD remain uncertain.
This study aims to evaluate the clinical efficacy and safety of auricular acupoint stimulation in FD patients with sleep disorders and to explore underlying mechanisms using brain-function assessments together with autonomic and gastrointestinal-related measures.
Sleep disturbance, anxiety, and depression are frequent in FD and are associated with symptom severity and recurrence. Current management-such as prokinetic agents, acid-suppressive therapy, and psychotropic medications when indicated-can be limited by variable efficacy, adverse effects, and concerns regarding long-term use. The pathophysiology of FD is multifactorial and incompletely understood; increasing evidence highlights dysregulation of the brain-gut axis and autonomic nervous system function (12,13). Auricular vagus nerve-related stimulation may influence brainstem neurotransmission, gastric tone/motility, and mood (14), suggesting a potentially safe, non-pharmacological approach for FD with comorbid sleep problems. However, the mechanistic links among autonomic regulation, gut microbiota/short-chain fatty acids, and FD remain uncertain.
This study aims to evaluate the clinical efficacy and safety of auricular acupoint stimulation in FD patients with sleep disorders and to explore underlying mechanisms using brain-function assessments together with autonomic and gastrointestinal-related measures.
Detailed Description:
In recent years, acupuncture therapy has become one of the most popular modalities within complementary and alternative medicine. Among acupuncture techniques, auricular point pressing therapy has been widely investigated in clinical and mechanistic studies for functional gastrointestinal disorders accompanied by negative emotions. Auricular point pressing therapy is based on the foundational theories of Traditional Chinese Medicine (TCM), specifically the meridian and visceral theories, combined with modern anatomical knowledge. It employs a syndrome differentiation approach to select relevant points on the ear. By applying appropriate rubbing, pressing, kneading, and compression to vaccaria seeds or other medicinal bean
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: