The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

NCT07334002 | Not Yet Recruiting

• 1 other identifier: 16.02.2021 / 3158
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. The study duration is 3 months.

Conditions

Tinnitus; Neural Therapy of Huneke

Keywords

Neural Therapy of Huneke; Tinnitus

Outcome Measures

Primary Outcomes (3)

• Turkish version of the Tinnitus Disability Questionnaire (THI)

  3 months

• SF-12 (short form)

  3 months

• Tinnitus severity according to VAS (visual analog scale)

  3 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Procedure: Neural Therapy of Huneke

Control Group

ACTIVE COMPARATOR

Drug: Betahistine 24 mg bid (Betaserc)

Interventions

Neural Therapy of Huneke PROCEDURE

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.

Treatment Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Also:
• Patients who have had ear surgery,
• Permanent hearing loss (total),
• Severe cardiovascular system failure, uncontrolled arrhythmia,
• Severe renal failure, or liver failure

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

MeSH Terms

Conditions

Tinnitus

Interventions

Anesthesia, Local; Betahistine; BID protein, human

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Roza Jizel Dağdelen, MD

CONTACT

+90 212 373 50 00; rozadagdelen@gmail.com

Jülide Öncü Alptekin, Professor Doctor, MD

CONTACT

+90507 231 6817; julideoncu@yahoo.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: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor , Assistant Researcher

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months