Functional DyspepsiaNCT05827575
Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial
A study testing Transcutaneous Auricular Vagal Nerve Stimulation in people with Functional Dyspepsia and Sleep Disturbances, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia, Sleep Disturbances
- What is being tested?
- Transcutaneous Auricular Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Functional bloating/distension with Rome IV;
- Pittsburgh Sleep Quality Index(PSQI)>7;
- Aged 18-65 years old；
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
Fei Dai, MD, 13772151298, daifei68@hotmail.com
Jingyao Li, 18392702742, 893139621@qq.com
About this study
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.
Read the 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.
- Conditions
- Functional Dyspepsia, Sleep Disturbances
- Being tested
- Transcutaneous Auricular Vagal Nerve Stimulation
- Keywords
- Transcutaneous Auricular Vagal Nerve Stimulation, Functional Dyspepsia, Sleep Disturbances
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagal Nerve StimulationDevice
stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz
| Study group | Role | What they receive |
|---|---|---|
| taVNS | Experimental | selected cavum conchae of the two ears for 25hz electrical stimulation Receives: Device: Transcutaneous Auricular Vagal Nerve Stimulation |
| sham-taVNS | Sham comparator | selected scapha of the two ears for 25hz electrical stimulation Receives: Device: Transcutaneous Auricular Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspepsia score
Nepean Dyspepsia Index：the symptom severity score and life quality score
Measured: after 4 weeks taVNS treatment
Sleep score
Pittsburgh Sleep Quality Index
Measured: after 4 weeks taVNS treatment
Hamilton Anxiety and Depression Scale score
Score of Hamilton Anxiety and Depression Scale
Measured: after 4 weeks taVNS treatment
Gastric slow waves in electrogastrograph
The percentage of the normal gastric slow waves in fasting, fed states and the post-preprandial EGG power ratio
Measured: after 4 weeks taVNS treatment
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).
Measured: after 4 weeks taVNS treatment
Heart rate variability（HRV）
Assessment of autonomic function with heart rate variability
Measured: after 4 weeks taVNS treatment
Serum melatonin (MLT) level
test the level of serum melatonin
Measured: after 4 weeks taVNS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start30 Mar 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827575
- Sponsor's protocol ID
- 2022006
- Status last verified
- Apr 2023
- First submitted
- 16 Jan 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05827575
- Acronym / sponsor ID
- 2022006
- Conditions
- Functional Dyspepsia, Sleep Disturbances
- Keywords
- Transcutaneous Auricular Vagal Nerve Stimulation, Functional Dyspepsia, Sleep Disturbances
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS | Experimental | Device: Transcutaneous Auricular Vagal Nerve Stimulationselected cavum conchae of the two ears for 25hz electrical stimulation |
| sham-taVNS | Sham comparator | Device: Transcutaneous Auricular Vagal Nerve Stimulationselected scapha of the two ears for 25hz electrical stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Functional bloating/distension with Rome IV;
- Pittsburgh Sleep Quality Index(PSQI)>7;
- Aged 18-65 years old；
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulationstimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz | Device | sham-taVNS, taVNS |
Primary outcome
Dyspepsia score
Time frame: after 4 weeks taVNS treatment
Nepean Dyspepsia Index：the symptom severity score and life quality score
Sleep score
Time frame: after 4 weeks taVNS treatment
Pittsburgh Sleep Quality Index
Hamilton Anxiety and Depression Scale score
Time frame: after 4 weeks taVNS treatment
Score of Hamilton Anxiety and Depression Scale
Gastric slow waves in electrogastrograph
Time frame: after 4 weeks taVNS treatment
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）
Time frame: after 4 weeks taVNS treatment
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）
Time frame: after 4 weeks taVNS treatment
Assessment of autonomic function with heart rate variability
Serum melatonin (MLT) level
Time frame: after 4 weeks taVNS treatment
test the level of serum melatonin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagal Nerve Stimulation in people with Functional Dyspepsia and Sleep Disturbances, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Dai (13772151298, daifei68@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspepsia score (time frame: after 4 weeks taVNS treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.