search
Back to results

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

Primary Purpose

Functional Dyspepsia, Sleep Disturbances

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous Auricular Vagal Nerve Stimulation
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Transcutaneous Auricular Vagal Nerve Stimulation, Functional Dyspepsia, Sleep Disturbances

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of Functional bloating/distension with Rome IV; Pittsburgh Sleep Quality Index(PSQI)>7; Aged 18-65 years old; Exclusion Criteria: Have taken drugs that may affect gastrointestinal motility and sleep in the past two week; The history of gastrointestinal surgery; With severe heart, liver and kidney diseases; 5.Pregnant and breastfeeding women; 6.Skin allergies.

Sites / Locations

  • The second affiliated hospital of xi'an jiaotong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

taVNS

sham-taVNS

Arm Description

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

selected scapha of the two ears for 25hz electrical stimulation

Outcomes

Primary Outcome Measures

Dyspepsia score
Nepean Dyspepsia Index:the symptom severity score and life quality score
Sleep score
Pittsburgh Sleep Quality Index
Hamilton Anxiety and Depression Scale score
Score of Hamilton Anxiety and Depression Scale
Gastric slow waves in electrogastrograph
The percentage of the normal gastric slow waves in fasting, fed states and the post-preprandial EGG power ratio
The threshold volume(TV)and maximal volume(MV)
Nutrient drinking satiety test: drink [100 g milk powder, 50 g chocolate powder (Cola Coa, Idilia Foods), and 1,120 mL water (0.6 Cal/mL, fat:19%, protein: 18%, carbohydrate: 63%)] at a speed of 60mL/min until reaching the threshold volume(TV)and maximal volume(MV).
Heart rate variability(HRV)
Assessment of autonomic function with heart rate variability
Serum melatonin (MLT) level
test the level of serum melatonin

Secondary Outcome Measures

Full Information

First Posted
January 16, 2023
Last Updated
April 12, 2023
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
search

1. Study Identification

Unique Protocol Identification Number
NCT05827575
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Sleep Disturbances
Keywords
Transcutaneous Auricular Vagal Nerve Stimulation, Functional Dyspepsia, Sleep Disturbances

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
taVNS
Arm Type
Experimental
Arm Description
selected cavum conchae of the two ears for 25hz electrical stimulation
Arm Title
sham-taVNS
Arm Type
Sham Comparator
Arm Description
selected scapha of the two ears for 25hz electrical stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous Auricular Vagal Nerve Stimulation
Intervention Description
stimulation on both ear within different area for 4 weeks;parameter:2s on,3s off,0.5ms,25hz
Primary Outcome Measure Information:
Title
Dyspepsia score
Description
Nepean Dyspepsia Index:the symptom severity score and life quality score
Time Frame
after 4 weeks taVNS treatment
Title
Sleep score
Description
Pittsburgh Sleep Quality Index
Time Frame
after 4 weeks taVNS treatment
Title
Hamilton Anxiety and Depression Scale score
Description
Score of Hamilton Anxiety and Depression Scale
Time Frame
after 4 weeks taVNS treatment
Title
Gastric slow waves in electrogastrograph
Description
The percentage of the normal gastric slow waves in fasting, fed states and the post-preprandial EGG power ratio
Time Frame
after 4 weeks taVNS treatment
Title
The threshold volume(TV)and maximal volume(MV)
Description
Nutrient drinking satiety test: drink [100 g milk powder, 50 g chocolate powder (Cola Coa, Idilia Foods), and 1,120 mL water (0.6 Cal/mL, fat:19%, protein: 18%, carbohydrate: 63%)] at a speed of 60mL/min until reaching the threshold volume(TV)and maximal volume(MV).
Time Frame
after 4 weeks taVNS treatment
Title
Heart rate variability(HRV)
Description
Assessment of autonomic function with heart rate variability
Time Frame
after 4 weeks taVNS treatment
Title
Serum melatonin (MLT) level
Description
test the level of serum melatonin
Time Frame
after 4 weeks taVNS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Functional bloating/distension with Rome IV; Pittsburgh Sleep Quality Index(PSQI)>7; Aged 18-65 years old; Exclusion Criteria: Have taken drugs that may affect gastrointestinal motility and sleep in the past two week; The history of gastrointestinal surgery; With severe heart, liver and kidney diseases; 5.Pregnant and breastfeeding women; 6.Skin allergies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Dai
Phone
13772151298
Email
daifei68@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyao Li
Phone
18392702742
Email
893139621@qq.com
Facility Information:
Facility Name
The second affiliated hospital of xi'an jiaotong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Dai, MD
Phone
13772151298
Email
daifei68@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jingyao Li
Phone
18392702742
Email
893139621@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs