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Completed

NCT Number: NCT07472257

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Regensburg, 93053, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acoustic Stimulation - 20 minutes

Other

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 minutes

Other

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,

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Effects of Acoustic Stimulation Techniques on Tinnitus

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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