NCT05827575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

January 16, 2023

Last Update Submit

April 12, 2023

Conditions

Functional DyspepsiaSleep Disturbances

Keywords

Transcutaneous Auricular Vagal Nerve StimulationFunctional DyspepsiaSleep Disturbances

Outcome Measures

Primary Outcomes (7)

  • Dyspepsia score

    Nepean Dyspepsia Index：the symptom severity score and life quality score

    after 4 weeks taVNS treatment

  • Sleep score

    Pittsburgh Sleep Quality Index

    after 4 weeks taVNS treatment

  • Hamilton Anxiety and Depression Scale score

    Score of Hamilton Anxiety and Depression Scale

    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

    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).

    after 4 weeks taVNS treatment

  • Heart rate variability（HRV）

    Assessment of autonomic function with heart rate variability

    after 4 weeks taVNS treatment

  • Serum melatonin (MLT) level

    test the level of serum melatonin

    after 4 weeks taVNS treatment

Study Arms (2)

taVNS

EXPERIMENTAL

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

Device: Transcutaneous Auricular Vagal Nerve Stimulation

sham-taVNS

SHAM COMPARATOR

selected scapha of the two ears for 25hz electrical stimulation

Device: Transcutaneous Auricular Vagal Nerve Stimulation

Interventions

Transcutaneous Auricular Vagal Nerve StimulationDEVICE

stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz

sham-taVNStaVNS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Fei Dai

CONTACT

13772151298daifei68@hotmail.com

Jingyao Li

CONTACT

18392702742893139621@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

April 25, 2023

Study Start

March 30, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(1)