Clinical trial NCT05827575: Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial
Official title: Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Dyspepsia
Sleep Disturbances
Keywords: Transcutaneous Auricular Vagal Nerve Stimulation
Functional Dyspepsia
Sleep Disturbances
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional dyspepsia(FD) is most common in functional gastrointestinal disorders whose rick factors include sleep disturbances. The medication treatment for functional dyspepsia with sleep disturbances has disadvantages such as addiction and withdrawal symptoms. Transcutaneous auricular vagal nerve stimulation(taVNS) is a new therapeutic method to improve dyspepsia and sleep. Study on taSNS for FD with sleep disturbances has not yet been explored.

Detailed description: Functional dyspepsia (FD) is most common in functional gastrointestinal disorders whose risk factors include sleep disturbances. The medication treatment for FD with sleep disturbances has disadvantages such as addiction and withdrawal symptoms. Transcutaneous auricular vagal nerve stimulation (taVNS) is a new therapeutic method to improve dyspepsia and sleep. The study on taVNS for FD with sleep disturbances has not yet been explored.60 participants who have FD and sleep disturbances are recruited from the department of the Second Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria follows: meeting the ROME IV diagnostic criteria of FD; Pittsburgh Sleep Quality Index(PSQI)\>7; aged 18-65 years old; not taking related drugs in past one month; from March 2022 to June 2023; sign informed consent. All patients were randomly divided into 2 groups and respectively treated with taVNS and sham-taVNS for four weeks. PSQI, Nepean dyspepsia index (NDI), electrogastrogram (ECG), nutrient drinking satiety test, Hamilton Anxiety and Depression Scale, heart rate variability (HRV) and serum melatonin (MLT) were recorded at baseline and after 4-week treatment. The effect and mechanism of taVNS for FD with sleep disturbances were investigated by comparing the indexes before and after treatment of taVNS and sham-taVNS groups. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an Jiaotong University.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Functional bloating/distension with Rome IV;
2. Pittsburgh Sleep Quality Index(PSQI)\>7;
3. Aged 18-65 years old；

Exclusion Criteria:

1. Have taken drugs that may affect gastrointestinal motility and sleep in the past two week;
2. The history of gastrointestinal surgery;
3. With severe heart, liver and kidney diseases;

5.Pregnant and breastfeeding women; 6.Skin allergies.

Primary outcomes:
measure: Dyspepsia score
timeFrame: after 4 weeks taVNS treatment
measure: Sleep score
timeFrame: after 4 weeks taVNS treatment
measure: Hamilton Anxiety and Depression Scale score
timeFrame: after 4 weeks taVNS treatment
measure: Gastric slow waves in electrogastrograph
timeFrame: after 4 weeks taVNS treatment
measure: The threshold volume(TV)and maximal volume（MV）
timeFrame: after 4 weeks taVNS treatment
measure: Heart rate variability（HRV）
timeFrame: after 4 weeks taVNS treatment
measure: Serum melatonin (MLT) level
timeFrame: after 4 weeks taVNS treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of xi'an jiaotong university
state: Shaanxi
Study officials:
References: