- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07472257
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
45
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Other: Acoustic stimulation with individual best stimulus - 20 minutes
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 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
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
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)
April 1, 2018
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
March 4, 2026
First Submitted That Met QC Criteria
March 13, 2026
First Posted (Actual)
March 16, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Otorhinolaryngologic Diseases
- Sensation Disorders
- Ear Diseases
- Hearing Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Tinnitus
- Investigative Techniques
- Therapeutics
- Complementary Therapies
- Sensory Art Therapies
- Physical Stimulation
- Acoustic Stimulation
Other Study ID 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.
Clinical Trials on Tinnitus
-
State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruiting
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
TC Erciyes UniversityThe Scientific and Technological Research Council of TurkeyCompleted
-
University of Dublin, Trinity CollegeRecruitingBimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus (NITESGON-ADT)Tinnitus, Subjective | Tinnitus | Chronic TinnitusIreland
-
Necmettin Erbakan UniversityActive, not recruitingSubjective Tinnitus | Neuromodulation | Chronic TinnitusTurkey (Türkiye)
-
Mohab MohammedNot yet recruitingPulsatile Tinnitus (Diagnosis)
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
Nicolas GninenkoRecruitingTinnitus, Subjective | Tinnitus, Bilateral | Tinnitus, Noise Induced | Tinnitus, Hearing Loss, Cochlear Implant UsersUnited States
Clinical Trials on Acoustic Stimulation - 20 minutes
-
University of BernCompletedHealthy | Alzheimer Disease | Mild Cognitive ImpairmentSwitzerland
-
Walter Reed Army Institute of Research (WRAIR)Philips HealthcareRecruitingPerformance | Sleep Deprivation | Sleep Restriction | Alertness | Acoustic StimulationUnited States
-
Michelle StepanNational Institute of Mental Health (NIMH); Brain & Behavior Research FoundationRecruitingAcoustic StimulationUnited States
-
Institut de Recerca Biomèdica de Lleida-Fundació...Not yet recruitingAlzheimer's Disease (AD) | Mild Cognitive Impairment (MCI) Amnestic | Cognitively UnimpairedSpain
-
Christian BaumannUniversity of Zurich; University Children's Hospital; Klinik Lengg AGCompletedParkinson DiseaseSwitzerland
-
Elena ControCompleted
-
University of California, DavisRecruiting
-
University Hospital Inselspital, BerneUniversity of BernSuspended
-
University Hospital Inselspital, BerneUniversity of BernCompletedQuality of Life | Cognitive Impairment, MildSwitzerland