TinnitusNCT05291078
Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus
A study testing A transcutaneous trigeminal nerve stimulator: High Frequency, A transcutaneous trigeminal nerve stimulator: Low Frequency and Sound Therapy in people with Tinnitus, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- A transcutaneous trigeminal nerve stimulator: High Frequency, A transcutaneous trigeminal nerve stimulator: Low Frequency and Sound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2020to 18 May 2021
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults suffering from tinnitus
- Participants must be 19 to 70 years of age, at the time of screening
- Patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in Tinnitus Handicap Inventory (THI) examination
- Patients with a hearing threshold of 70dB or less when calculated using the quadrant method in the pure tone audiometry
- A person who has no physical or mental restrictions in participating in clinical trial
- Those who voluntarily agreed to participate in clinical trials
- A person who has no pregnancy plan and has agreed to the contraceptive plan for infertile women during the intervention period of clinical trial
Who cannot join
- A person who does not meet the inclusion criteria
- A person who has difficulty communicating and conducting examinations.
- The disease of the outer or middle ear or central nervous system.
- Subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment
- Pregnant or lactating women
- A person who cannot understand or read ICF (illiterate or foreigner)
- A person who received tinnitus treatment (blood circulation enhancer, tranquilizer, tinnitus masker, biofeedback etc.) within 2 weeks of baseline or plans to receive it.
- A person who is difficult to participate in a clinical trial according to the researcher's judgment. (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head \& neck. Patient suffering from unknown pain. Patients who are warned not to use out clinical trial device or is prohibited from using it.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Otorhinolaryngology, Samsung Medical Center
Seoul, 06351
About this study
Official title: Exploring the Effects of Transcutaneous Trigeminal Nerve Stimulation Using NUEYNE-T30 and NUEYNE-T100 and Sound Fusion Stimulation on Tinnitus: A Single-center, Double Blind, Placebo-controlled Group, Investigator Initiated Study (IIT) Study
This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.
Read the detailed description
Duration of study period (per participant): Screening period (-7~0 days), Intervention period (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done with screening visit. Tele-visit should be done on day 15.
- Conditions
- Tinnitus
- Being tested
- A transcutaneous trigeminal nerve stimulator: High Frequency, A transcutaneous trigeminal nerve stimulator: Low Frequency, A transcutaneous trigeminal nerve stimulator: Sham, Sound Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A transcutaneous trigeminal nerve stimulator: High FrequencyDevice
30min/day, at least 5 to 7 times a week
A transcutaneous trigeminal nerve stimulator: Low FrequencyDevice
30min/day, at least 5 to 7 times a week
A transcutaneous trigeminal nerve stimulator: ShamDevice
30min/day, at least 5 to 7 times a week
Sound TherapyDevice
Notch Therapy at least 30min/day, at least 5 to 7 times a week
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | Tinnitus patients(n=12 people) Receives: Device: A transcutaneous trigeminal nerve stimulator: High Frequency; Device: Sound Therapy |
| Experimental Group B | Experimental | Tinnitus patients(n=12 people) Receives: Device: A transcutaneous trigeminal nerve stimulator: Low Frequency; Device: Sound Therapy |
| Control Group | Sham comparator | Tinnitus patients(n=12 people) Receives: Device: A transcutaneous trigeminal nerve stimulator: Sham; Device: Sound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Tinnitus handicap inventory(THI) score
Check the changes in Tinnitus handicap inventory(THI) score
The score on the questionnaire ranges from 0 to 100. Higher scores mean a worse outcome.
Measured: baseline, 4 weeks
Secondary outcomes (8)
Changes in Loudness of Tinnitogram
Check the changes in Loudness of Tinnitogram
Measured: baseline, 4 weeks
Changes in Minimal masking level of Tinnitogram
Check the changes in Minimal masking level of Tinnitogram
Measured: baseline, 4 weeks
Changes in Tinnitus magnitude index(TMI) score
Check the changes in Tinnitus magnitude index(TMI) score
The questionnaire consists of three questions. The score for No. 1 question ranges from 0 to 10. The score for No. 2 question ranges from 0% to 10%. The score for No. 2 question ranges from 0mm to 100mm. Higher scores mean a worse outcome.
Measured: baseline, 4 weeks
Changes in EEG
Check the changes in EEG
Measured: baseline, 4 weeks
Changes in PPG
Check the changes in PPG
Measured: baseline, 4 weeks
Changes in Beck Depression Inventory(BDI) score
Check the changes in Beck Depression Inventory score
The score on the questionnaire ranges from 0 to 63. Higher scores mean a worse outcome.
Measured: baseline, 4 weeks
Changes in Pittsburg Sleep Quality Index (PSQI) score
Check the changes in Pittsburg Sleep Quality Index (PSQI) score
The score on the questionnaire ranges from 0 to 21. Higher scores mean a worse outcome.
Measured: baseline, 4 weeks
Changes in MOS Short-Form 36-Item Health Survey(SF-36) score
Check the changes in MOS Short-Form 36-Item Health Survey(SF-36) score
The questionnaire consists of 8 subscales. The score for each subscale ranges from 0 to 100. Higher scores mean a better outcome.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start22 Oct 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iljoon Moon, Ph. D., MD., Principal investigator, Department of Otorhinolaryngology, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291078
- Sponsor's protocol ID
- NE_TNT_IIT001
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 11 Sep 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Transcutaneous Trigeminal Nerve Stimulation Using NUEYNE-T30 and NUEYNE-T100 and Sound Fusion Stimulation on Tinnitus: A Single-center, Double Blind, Placebo-controlled Group, Investigator Initiated Study (IIT) Study
- ClinicalTrials.gov ID
- NCT05291078
- Acronym / sponsor ID
- NE_TNT_IIT001
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 22 Mar 2022 (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.
This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.
Detailed description
Duration of study period (per participant): Screening period (-7~0 days), Intervention period (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done with screening visit. Tele-visit should be done on day 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Device: A transcutaneous trigeminal nerve stimulator: High Frequency, Device: Sound TherapyTinnitus patients(n=12 people) |
| Experimental Group B | Experimental | Device: A transcutaneous trigeminal nerve stimulator: Low Frequency, Device: Sound TherapyTinnitus patients(n=12 people) |
| Control Group | Sham comparator | Device: A transcutaneous trigeminal nerve stimulator: Sham, Device: Sound TherapyTinnitus patients(n=12 people) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults suffering from tinnitus
- Participants must be 19 to 70 years of age, at the time of screening
- Patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in Tinnitus Handicap Inventory (THI) examination
- Patients with a hearing threshold of 70dB or less when calculated using the quadrant method in the pure tone audiometry
- A person who has no physical or mental restrictions in participating in clinical trial
Key exclusion criteria (8 listed)
- A person who does not meet the inclusion criteria
- A person who has difficulty communicating and conducting examinations.
- The disease of the outer or middle ear or central nervous system.
- Subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment
- 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 |
|---|---|---|
| A transcutaneous trigeminal nerve stimulator: High Frequency30min/day, at least 5 to 7 times a week | Device | Experimental Group A |
| A transcutaneous trigeminal nerve stimulator: Low Frequency30min/day, at least 5 to 7 times a week | Device | Experimental Group B |
| A transcutaneous trigeminal nerve stimulator: Sham30min/day, at least 5 to 7 times a week | Device | Control Group |
| Sound TherapyNotch Therapy at least 30min/day, at least 5 to 7 times a week | Device | Control Group, Experimental Group A, Experimental Group B |
Primary outcome
Changes in Tinnitus handicap inventory(THI) score
Time frame: baseline, 4 weeks
Check the changes in Tinnitus handicap inventory(THI) score The score on the questionnaire ranges from 0 to 100. Higher scores mean a worse outcome.
8 secondary outcomes
Changes in Loudness of Tinnitogram
Time frame: baseline, 4 weeks
Changes in Minimal masking level of Tinnitogram
Time frame: baseline, 4 weeks
Changes in Tinnitus magnitude index(TMI) score
Time frame: baseline, 4 weeks
Changes in EEG
Time frame: baseline, 4 weeks
Changes in PPG
Time frame: baseline, 4 weeks
Changes in Beck Depression Inventory(BDI) score
Time frame: baseline, 4 weeks
Changes in Pittsburg Sleep Quality Index (PSQI) score
Time frame: baseline, 4 weeks
Changes in MOS Short-Form 36-Item Health Survey(SF-36) score
Time frame: baseline, 4 weeks
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 11 Sep 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.
Iljoon Moon, Ph. D., MD. principal investigator
Department of Otorhinolaryngology, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A transcutaneous trigeminal nerve stimulator: High Frequency, A transcutaneous trigeminal nerve stimulator: Low Frequency and Sound Therapy in people with Tinnitus, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
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 7 inclusion and 8 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 11 Sep 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 South Korea. 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?
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?
Changes in Tinnitus handicap inventory(THI) score (time frame: baseline, 4 weeks). 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 11 Sep 2023.