TinnitusNCT07334002
The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus
A study testing Neural Therapy of Huneke and Betahistine 24 mg bid (Betaserc) in people with Tinnitus and Neural Therapy of Huneke, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus. The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus, Neural Therapy of Huneke
- What is being tested?
- Neural Therapy of Huneke and Betahistine 24 mg bid (Betaserc)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 26 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).
Who cannot join
- Patients with a disease that may cause objective tinnitus,
- Otosclerosis,
- Chronic otitis media,
- Acoustic tumor,
- Meniere's disease,
- History of ear surgery or head trauma, and those with neuropsychiatric diseases.
Show all 11Show fewer
- Also:
- Patients who have had ear surgery,
- Permanent hearing loss (total),
- Severe cardiovascular system failure, uncontrolled arrhythmia,
- Severe renal failure, or liver failure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Single-blind, Controlled Trial to Evaluate the Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus
A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus.
The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.
Read the detailed description
All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.
- Conditions
- Tinnitus, Neural Therapy of Huneke
- Being tested
- Neural Therapy of Huneke, Betahistine 24 mg bid (Betaserc)
- Keywords
- Neural Therapy of Huneke, Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Therapy of HunekeProcedure or surgery
The aim for tinnitus and facial pain is to regulate the trigeminal system and autonomic balance.
Concentration used: Lidocaine 0.5%.
The auriculotemporal, infraorbital, zygomaticotemporal, and stellate regions were targeted.
Puncture applications: 0.3-0.5 mL will be administered behind the ear, around the mastoid process, behind the tragus, and in the temporomandibular region.
If necessary, the stellate ganglion area can be supplemented with regulation injections.
Negative aspiration and aseptic technique will be applied before each application.
Transient mild dizziness or local redness may occur after application.
To avoid the risk of systemic toxicity, the total dose should generally not exceed a maximum of 200 mg of lidocaine.
Betahistine 24 mg bid (Betaserc)Drug
Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Procedure: Neural Therapy of Huneke |
| Control Group | Active comparator | Not described Receives: Drug: Betahistine 24 mg bid (Betaserc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish version of the Tinnitus Disability Questionnaire (THI)
Measured: 3 months
SF-12 (short form)
Measured: 3 months
Tinnitus severity according to VAS (visual analog scale)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion26 May 2026 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roza Jizel Dagdelen MD, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334002
- Sponsor's protocol ID
- 16.02.2021 / 3158
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Controlled Trial to Evaluate the Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus
- ClinicalTrials.gov ID
- NCT07334002
- Acronym / sponsor ID
- 16.02.2021 / 3158
- Conditions
- Tinnitus, Neural Therapy of Huneke
- Keywords
- Neural Therapy of Huneke, Tinnitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 26 May 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus.
The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.
Detailed description
All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Neural Therapy of Huneke |
| Control Group | Active comparator | Drug: Betahistine 24 mg bid (Betaserc) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).
Key exclusion criteria (11 listed)
- Patients with a disease that may cause objective tinnitus,
- Patients who have had ear surgery,
- Permanent hearing loss (total),
- Severe cardiovascular system failure, uncontrolled arrhythmia,
- Severe renal failure, or liver failure
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 |
|---|---|---|
| Neural Therapy of HunekeThe aim for tinnitus and facial pain is to regulate the trigeminal system and autonomic balance. Concentration used: Lidocaine 0.5%. The auriculotemporal, infraorbital, zygomaticotemporal, and stellate regions were targeted. Puncture applications: 0.3-0.5 mL will be administered behind the ear, around the mastoid process, behind the tragus, and in the temporomandibular region. If necessary, the stellate ganglion area can be supplemented with regulation injections. Negative aspiration and aseptic technique will be applied before each application. Transient mild dizziness or local redness may occur after application. To avoid the risk of systemic toxicity, the total dose should generally not exceed a maximum of 200 mg of lidocaine. | Procedure or surgery | Treatment Group |
| Betahistine 24 mg bid (Betaserc)Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity. | Drug | Control Group |
Primary outcome
Turkish version of the Tinnitus Disability Questionnaire (THI)
Time frame: 3 months
SF-12 (short form)
Time frame: 3 months
Tinnitus severity according to VAS (visual analog scale)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Therapy of Huneke and Betahistine 24 mg bid (Betaserc) in people with Tinnitus and Neural Therapy of Huneke, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 11 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: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roza Jizel Dağdelen, MD (+90 212 373 50 00, rozadagdelen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish version of the Tinnitus Disability Questionnaire (THI) (time frame: 3 months). 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 23 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.