NCT07472257

Brief Summary

This study compared tinnitus suppression after 3-minute and 20-minute acoustic stimulation using an individually optimized stimulus. In total 45 tinnitus patients participated. Thirty-three participants with chronic subjective tinnitus completed three sessions. During the first two sessions, eight individualized filtered and modulated stimuli were presented for 3 minutes each to identify the stimulus inducing the strongest tinnitus suppression. This stimulus was subsequently applied for 20 minutes in the third session.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 4, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

tinnitusresidual inhibitionacoustic stimulation

Outcome Measures

Primary Outcomes (1)

  • Short-term tinnitus loudness suppression

    Tinnitus loudness ratings are obtained immediately after each acoustic stimulation application at seven time points (every 30 seconds: t0, t30, t60, t90, t120, t150, and t180) using a numeric rating scale ranging from 0-110%. A rating of 100% indicates tinnitus loudness equal to the pre-stimulation level, values above 100% indicate increased loudness, and values below 100% indicate reduced loudness.

    From immediately after acoustic stimulation until 180 seconds post-stimulation. start: immediately after stimulation end: 180 seconds post-stimulation

Study Arms (2)

Acoustic stimulation with individual best stimulus - 20 minutes

OTHER

Acoustic stimulation - 20 minutes

Other: Acoustic Stimulation - 20 minutes

Acoustic stimulation with individual best stimulus - 3 minutes

OTHER

Acoustic stimulation - 3 minutes

Other: Acoustic stimulation - 3 minutes

Interventions

For each participant, the stimulus which induced the strongest tinnitus loudness suppression (measured with a numeric rating scale in percent compared to baseline loudness) during the previous 2 sessions was chosen and then applied for 20 minutes in a third session.

Acoustic stimulation with individual best stimulus - 20 minutes

Other: Acoustic stimulation Description: sound stimuli were presented diotically with a 1000ms fade-in and fade-out phase in randomized order; in two sessions the following stimuli were applied for 3 minutes each: White Noise (WN), WN with a bandpass filter (WN\_BP) and WN with a bandstop filter (WN\_BS), both filters applied at the individual tinnitus frequency (ITF); different pure tones: one at the ITF, two at the ITF with amplitude modulation at either 10 Hz or 23 Hz (AM\_10Hz, AM\_23Hz) and another two low-frequency tones (three octaves below the patient's ITF) with an amplitude modulation at 10 Hz or 23 Hz as well (AM\_10Hz\_deep, AM\_23Hz\_deep); For each participant, the stimulus which induced the strongest tinnitus loudness suppression (measured with a numeric rating scale in percent compared to baseline loudness) was chosen,

Acoustic stimulation with individual best stimulus - 3 minutes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic tinnitus, defined as a tinnitus duration of at least 6 months
  • Written informed consent: The patient must be able to understand the study information, comply with the required examinations and appointments, and provide written informed consent
  • Male or female patients, aged 18-75 years

You may not qualify if:

  • Objective tinnitus
  • Tinnitus below 1000 Hz
  • Presence of Menière's disease, otosclerosis, acoustic neuroma, or other clearly identifiable and treatable causes of tinnitus
  • Initiation of other tinnitus treatments within the last three months prior to study entry
  • Lack of informed consent
  • Oropharyngeal infection
  • Presence of clinically relevant severe internal, neurological, or psychiatric disorders
  • Drug, medication, or alcohol abuse within 12 weeks prior to study entry
  • Any other condition that, in the opinion of the investigator, makes participation in the study unsuitable
  • Hyperacusis
  • Current pharmacological treatment with psychoactive substances (e.g., antidepressants, anticonvulsants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSensory Art TherapiesComplementary TherapiesPhysical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Berthold Langguth

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 16, 2026

Study Start

April 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

not relevant

Locations