Meniere DiseaseNCT04686695
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease
A study testing taVNS in people with Meniere Disease, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Read more about this study
- Who is it for?
- Ages 40 to 66 years
- Conditions the study is for
- Meniere Disease
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 May 2020
- 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 40 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 and Age <=70.
- Clinical diagnosis of meniere disease.
Who cannot join
- History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- History of Otorhinolaryngology surgery.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.
Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.
Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.
A difference of P < 0.05 was considered statistically significant.
- Conditions
- Meniere Disease
- Being tested
- taVNS
- Keywords
- Transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Experimental | Not described Receives: Device: taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms
Measured: Day 0 and postintervention at Week 12
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
DHI to measure the subjective dizziness symptoms.
Measured: Day 0 and postintervention at Week 12
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
Pure Tone Audiometry to measure the audition.
Measured: Day 0 and postintervention at Week 12
Secondary outcomes (2)
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
SF-36 to measure quality of life
Measured: Day 0 and postintervention at Week 12
Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks
Visual scale to measure the subjective ear stuffiness symptoms
Measured: Day 0 and postintervention at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686695
- Sponsor's protocol ID
- taVNS-MD-2020
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT04686695
- Acronym / sponsor ID
- taVNS-MD-2020
- Conditions
- Meniere Disease
- Keywords
- Transcutaneous auricular vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 29 Dec 2020 (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.
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.
Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.
Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.
A difference of P < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Experimental | Device: taVNS |
Who may qualify
- Ages
- 40 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >=18 and Age <=70.
- Clinical diagnosis of meniere disease.
Key exclusion criteria (3 listed)
- History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- History of Otorhinolaryngology surgery.
- Pregnant or lactating women.
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 |
|---|---|---|
| taVNStaVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily. | Device | Transcutaneous Auricular Vagus Nerve Stimulation |
Primary outcome
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
Time frame: Day 0 and postintervention at Week 12
Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
Time frame: Day 0 and postintervention at Week 12
DHI to measure the subjective dizziness symptoms.
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
Time frame: Day 0 and postintervention at Week 12
Pure Tone Audiometry to measure the audition.
2 secondary outcomes
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
Time frame: Day 0 and postintervention at Week 12
Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks
Time frame: Day 0 and postintervention at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Meniere Disease, run by Beijing Tongren Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jun 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks (time frame: Day 0 and postintervention at Week 12). The study lists 3 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 18 Jun 2024.