TinnitusNCT07472257
The Longer, the Better? Investigating the Effect of Prolonged Acoustic Stimulation on Brief Acoustic Tinnitus Suppression
A study testing Acoustic Stimulation - 20 minutes and Acoustic stimulation - 3 minutes in people with Tinnitus, run by University of Regensburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Acoustic Stimulation - 20 minutes and Acoustic stimulation - 3 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany
Regensburg, 93053
About this study
Official title: 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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Acoustic Stimulation - 20 minutes, Acoustic stimulation - 3 minutes
- Keywords
- tinnitus, residual inhibition, acoustic stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Stimulation - 20 minutesOther
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 - 3 minutesOther
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,
| Study group | Role | What they receive |
|---|---|---|
| Acoustic stimulation with individual best stimulus - 20 minutes | Other | Acoustic stimulation - 20 minutes Receives: Other: Acoustic Stimulation - 20 minutes |
| Acoustic stimulation with individual best stimulus - 3 minutes | Other | Acoustic stimulation - 3 minutes Receives: Other: Acoustic stimulation - 3 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From immediately after acoustic stimulation until 180 seconds post-stimulation. start: immediately after stimulation end: 180 seconds post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472257
- Sponsor's protocol ID
- 17-819-101
- Other IDs
- agreement number 722046, Swiss National Fund 'Early Pos
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not relevant
Publications
Rischer J, Neff P, Langguth B, Engelke M, Reissmann A, Schoisswohl S. The longer, the better? Investigating the effect of prolonged acoustic stimulation on brief acoustic tinnitus suppression. BMC Neurol. 2026 Jun 30;26(1):417. doi: 10.1186/s12883-026-04997-0.
PubMed 42380788
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acoustic Stimulation Techniques on Tinnitus
- ClinicalTrials.gov ID
- NCT07472257
- Acronym / sponsor ID
- 17-819-101
- Conditions
- Tinnitus
- Keywords
- tinnitus, residual inhibition, acoustic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acoustic stimulation with individual best stimulus - 20 minutes | Other | Other: Acoustic Stimulation - 20 minutesAcoustic stimulation - 20 minutes |
| Acoustic stimulation with individual best stimulus - 3 minutes | Other | Other: Acoustic stimulation - 3 minutesAcoustic stimulation - 3 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic Stimulation - 20 minutesFor 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 - 20 minutes |
| Acoustic stimulation - 3 minutesOther: 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, | Other | Acoustic stimulation with individual best stimulus - 3 minutes |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 42380788Rischer J, Neff P, Langguth B, Engelke M, Reissmann A, Schoisswohl S. The longer, the better? Investigating the effect of prolonged acoustic stimulation on brief acoustic tinnitus suppression. BMC Neurol. 2026 Jun 30;26(1):417. doi: 10.1186/s12883-026-04997-0.
- Individual participant dataSharing planned: No. not relevant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic Stimulation - 20 minutes and Acoustic stimulation - 3 minutes in people with Tinnitus, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07472257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.