Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial

Xi'an Jiaotong University

Status: Enrolling

Conditions: Functional Dyspepsia; Sleep Disturbances

Treatments: Device: Transcutaneous Auricular Vagal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05827575

2022006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

taVNS

Experimental group

Description:

selected cavum conchae of the two ears for 25hz electrical stimulation

Treatment:

Device: Transcutaneous Auricular Vagal Nerve Stimulation

sham-taVNS

Sham Comparator group

Description:

selected scapha of the two ears for 25hz electrical stimulation

Treatment:

Device: Transcutaneous Auricular Vagal Nerve Stimulation