The Longer, the Better? Investigating the Effect of Prolonged Acoustic Stimulation on Brief Acoustic Tinnitus Suppression

March 13, 2026 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Effects of Acoustic Stimulation Techniques on Tinnitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study comprised three experimental acoustic stimulation sessions. In session one, audiometric and tinnitometric assessments were conducted, followed by stimulation with three noise stimuli: white noise (WN), white noise with a bandstop filter (WN_BS), and white noise with a bandpass filter (WN_BP), each implemented with a one-octave filter around the individual tinnitus frequency (ITF). Session two (3-14 days later) included five pure tone stimuli: a tone at the ITF, two amplitude-modulated tones at the ITF (10 Hz, 23 Hz), and two amplitude-modulated tones three octaves below the ITF (10 Hz, 23 Hz). Stimuli were presented diotically for 3 minutes with 1000 ms fade-in/out, separated by 6-minute breaks. Participants experiencing brief acoustic tinnitus suppression (BATS) in session one or two completed a third session, in which the stimulus inducing the strongest suppression was applied for 20 minutes. Tinnitus loudness was rated immediately after stimulation using a numeric rating scale (0-110% of baseline loudness) at multiple time points up to 180 seconds, and up to 600 seconds after the 20-minute stimulation to capture prolonged suppression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93053
        • Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Acoustic stimulation with individual best stimulus - 20 minutes
Acoustic stimulation - 20 minutes
Other: Acoustic Stimulation - 20 minutes
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.
Other: Acoustic stimulation with individual best stimulus - 3 minutes
Acoustic stimulation - 3 minutes
Other: Acoustic stimulation - 3 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,

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short-term tinnitus loudness suppression
Time Frame: From immediately after acoustic stimulation until 180 seconds post-stimulation. start: immediately after stimulation end: 180 seconds post-stimulation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Regensburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-819-101
  • agreement number 722046 (Other Grant/Funding Number: European Union's Horizon 2020 research and innovation program under the Marie SklodowskaCurie grant)
  • Swiss National Fund 'Early Pos (Other Grant/Funding Number: P2ZHP1 174967)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not relevant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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