Meniere DiseaseNCT06544590
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease
An observational study of 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 enrolled 231 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 18 to 65 years
- Conditions the study is for
- Meniere Disease
- What is being tested?
- taVNS and Betahistine Mesylate tablet
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 10 Jul 2024
- Phase
- Observational
- 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
Study population: Meniere Disease is a clinical condition defined by hearing loss, tinnitus, and aural fullness symptoms, there are currently no any medications approved for its treatment. The aim of study is to determine taVNS as an adjunctive therapy could relieve symptoms in treatment period and follow-up period in patients with Meniere disease. Outcome measures include vHIT, the Caloric Test, THI, DHI, Pure Tone Auditory, and VAS.
Who may be able to join
- 1. Age >=18 and Age <=65. 2. 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.
China1 site
China Beijing TongRen Hospital, Capital Medical University Beijing, China
Beijing, Beijing Municipality, 100730
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: A Retrospective Study
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.
Methods: We enrolled 231 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, 3 months, 6 months, and 12 months. Video head impulse test (VHIT), the caloric test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.
- Conditions
- Meniere Disease
- Being tested
- taVNS, Betahistine Mesylate tablet
- Keywords
- Meniere Disease, taVNS, case-control, retrospective
- 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 device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms [18,28]. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. In the taVNS group received 12 weeks of treatment (30 min each time, once daily, 5 times per week).
Betahistine Mesylate tabletDrug
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Drug: Betahistine Mesylate tablet | |
| taVNS group | Not described Receives: Device: taVNS; Drug: Betahistine Mesylate tablet | |
| sham taVNS group | Not described Receives: Device: taVNS; Drug: Betahistine Mesylate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video head impulse test (VHIT)
VHIT was used to assess the function of all the six SCCs by measuring the gain of the vestibulo-ocular reflex. The instrument comprises an inertial measurement unit to measure movements of the head and an infrared camera to record eye movements. HIT can calculate the mean gain value (ratio of eye to head velocity) for each of the six SCCs, and also detect covert or overt saccades. During the test, goggles were secured firmly to patients' head to ensure that the goggles did not slip from the face during head movement. Patients sat ~1.5 m in front of a wall on which a visual target was affixed. Before testing, head movement and eye movement were calibrated according to the manufacturer's instructions.
According to manufacture recommendations, normal gain values are expected to range between 0.80 and 1.20 for horizontal canals, and 0.70-1.20 for vertical canals. Pathological saccades and gain values below the normal range were recorded.
Measured: Baseline, month 3, 6 and 12
Secondary outcomes (5)
The caloric test
The caloric test was employed to evaluate the horizontal semicircular canal (SCC). The patients took supine position and raised their head to 30 degrees with a pillow. The right and left ears of the patients were stimulated with cool air (24°C) and warm air (50°C) by using an air caloric irrigator system (Micromedical Technologies Inc., Chatham, IL, USA) and a Brookler-Grams closed-loop irrigation unit. We used videonystagmography (VNG) (Ulmer Inc. Marseille, France) to record horizontal eye movements during the test. The subjects were perfused four times for 60 s.
After perfusion, the nystagmus was observed for 60 s. Unilateral Weakness (UW) was calculated using the maximal slow phase eye velocity: UW = | (RC + RW) - (LC + LW) | / (RC + RW +LC + LW) × 100%, where RC = right cool, RW
= right warm, LC = left cool, and LW = left warm. UW >25% was considered abnormal.
Measured: Baseline, month 3, 6 and 12
Tinnitus Handicap Inventory (THI)
The THI is a 25-items, self-reported questionnaire regarding tinnitus handicap in daily life. The questionnaire comprises a 12-item functional subscale, an 8-item emotional subscale, and a 5-item catastrophic subscale. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of tinnitus symptoms.
measure the subjective tinnitus symptoms.
Measured: Baseline, month 3, 6 and 12
Dizziness Handicap Inventory (DHI)
The DHI is 25-items self-reported questionnaire that used to evaluate the functional, emotional, and physical impact of dizziness on patients' daily life. Among the overall 25 items of questions, 9 items are emotional related, 9 items are functional related, and 7 items are physical related questions. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of dizziness symptoms.
Measured: Baseline, month 3, 6 and 12
Pure tone thresholds
The pure tone thresholds was performed in a sound-attenuated, double-walled booth with circumaural headphones (Sennheiser HD 280 for frequencies from 250 to 8000 Hz and Sennheiser HD 200 for frequencies from 8000 to 14000 Hz; Sennheiser, Old Lyme, USA) on a certified and calibrated audiometric system (Interacoustics, Middelfart, Denmark).
Thresholds were measured using a probe-detection paradigm with pure tones presented for 250 ms at frequencies of 250, 500, 1000, 2000, 4000, 8000 Hz for each ear. To determine the LDL, the volume was set to 75 dB at 1000 Hz and then continuously raised in 5 dB steps (every 5 s) until the subject gave the signal that this volume was uncomfortable.
When the volume exceeded 110 dB the test was stopped to prevent any hearing damage.
The severity of hearing impairment was calculated as mild (20-40 dB), moderate (41-70 dB), severe (71-95 dB) and profound (>95 dB). Normal hearing was defined as pure-tone thresholds less than 20 dB.
Measured: Baseline, month 3, 6 and 12
Visual analogue scale (VAS)
The VAS scale of aural fullness consists of a 100 mm straight line with defined endpoints ("no aural fullness" and "worst aural fullness imaginable") on which the patients were asked to mark their experienced aural fullness (results in mm) at the actual time ("VAS now"). The higher VAS score (Range: 0-100) is correlated with a severe aural fullness.
Measured: Baseline, month 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2019
- Primary completion1 Jul 2024
- Study completion10 Jul 2024
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 77 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
- NCT06544590
- Sponsor's protocol ID
- taVNS-MD-2024
- Status last verified
- Jul 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06544590
- Acronym / sponsor ID
- taVNS-MD-2024
- Conditions
- Meniere Disease
- Keywords
- Meniere Disease, taVNS, case-control, retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 9 Aug 2024 (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 enrolled 231 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, 3 months, 6 months, and 12 months. Video head impulse test (VHIT), the caloric test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Drug: Betahistine Mesylate tablet |
| taVNS group | – | Device: taVNS, Drug: Betahistine Mesylate tablet |
| sham taVNS group | – | Device: taVNS, Drug: Betahistine Mesylate tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meniere Disease is a clinical condition defined by hearing loss, tinnitus, and aural fullness symptoms, there are currently no any medications approved for its treatment. The aim of study is to determine taVNS as an adjunctive therapy could relieve symptoms in treatment period and follow-up period in patients with Meniere disease. Outcome measures include vHIT, the Caloric Test, THI, DHI, Pure Tone Auditory, and VAS.
Key inclusion criteria (1 listed)
- 1. Age >=18 and Age <=65. 2. 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 device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms [18,28]. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. In the taVNS group received 12 weeks of treatment (30 min each time, once daily, 5 times per week). | Device | sham taVNS group, taVNS group |
| Betahistine Mesylate tabletBetahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day. | Drug | Control group, sham taVNS group, taVNS group |
Primary outcome
Video head impulse test (VHIT)
Time frame: Baseline, month 3, 6 and 12
VHIT was used to assess the function of all the six SCCs by measuring the gain of the vestibulo-ocular reflex. The instrument comprises an inertial measurement unit to measure movements of the head and an infrared camera to record eye movements. HIT can calculate the mean gain value (ratio of eye to head velocity) for each of the six SCCs, and also detect covert or overt saccades. During the test, goggles were secured firmly to patients' head to ensure that the goggles did not slip from the face during head movement. Patients sat ~1.5 m in front of a wall on which a visual target was affixed. Before testing, head movement and eye movement were calibrated according to the manufacturer's instructions. According to manufacture recommendations, normal gain values are expected to range between 0.80 and 1.20 for horizontal canals, and 0.70-1.20 for vertical canals. Pathological saccades and gain values below the normal range were recorded.
5 secondary outcomes
The caloric test
Time frame: Baseline, month 3, 6 and 12
Tinnitus Handicap Inventory (THI)
Time frame: Baseline, month 3, 6 and 12
Dizziness Handicap Inventory (DHI)
Time frame: Baseline, month 3, 6 and 12
Pure tone thresholds
Time frame: Baseline, month 3, 6 and 12
Visual analogue scale (VAS)
Time frame: Baseline, month 3, 6 and 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 9 Aug 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?
An observational study of 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 1 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 9 Aug 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?
Video head impulse test (VHIT) (time frame: Baseline, month 3, 6 and 12). 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 9 Aug 2024.