Biomodulator Patch for Subjective Tinnitus

NCT07731230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-07-30

No results posted yet for this study

Summary

This study tested whether a skin patch, worn behind the ear, could help reduce tinnitus (ringing or buzzing in the ears) in adults. Eighty participants took part. Half wore an active patch, and half wore a patch that looked the same but had no active effect (a placebo). Neither the participants nor the researchers knew who received which patch until the study ended.

All participants also received an educational counseling session about tinnitus and how to manage it. Participants were assessed before treatment, three weeks later, about seven weeks later, and again about one year later. The researchers measured how much tinnitus affected their daily life, their sensitivity to sound, and their anxiety or mood.

Conditions

Interventions

DEVICE

Steady-State Coherent Biomodulator Patch (Antinitus)

A passive, light photon-driven biomodulator patch applied behind the ear and replaced daily for three weeks, intended to influence auditory neural activity through effects on tissue water coherency.

DEVICE

Placebo Patch

A patch visually indistinguishable from the active biomodulator patch but without active photon-driven effect, applied behind the ear and replaced daily for three weeks

Sponsors & Collaborators

  • Murat Erinç

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2020-02-27
Completion
2021-02-27

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731230 on ClinicalTrials.gov