Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07472257
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Longer, the Better? Investigating the Effect of Prolonged Acoustic Stimulation on Brief Acoustic Tinnitus Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000161', 'term': 'Acoustic Stimulation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term tinnitus loudness suppression', 'timeFrame': 'From immediately after acoustic stimulation until 180 seconds post-stimulation. start: immediately after stimulation end: 180 seconds post-stimulation', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tinnitus', 'residual inhibition', 'acoustic stimulation'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Diagnosis of chronic tinnitus, defined as a tinnitus duration of at least 6 months\n* 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\n* Male or female patients, aged 18-75 years\n\nExclusion criteria:\n\n* Objective tinnitus\n* Tinnitus below 1000 Hz\n* Presence of Menière's disease, otosclerosis, acoustic neuroma, or other clearly identifiable and treatable causes of tinnitus\n* Initiation of other tinnitus treatments within the last three months prior to study entry\n* Lack of informed consent\n* Oropharyngeal infection\n* Presence of clinically relevant severe internal, neurological, or psychiatric disorders\n* Drug, medication, or alcohol abuse within 12 weeks prior to study entry\n* Any other condition that, in the opinion of the investigator, makes participation in the study unsuitable\n* Hyperacusis\n* Current pharmacological treatment with psychoactive substances (e.g., antidepressants, anticonvulsants)"}, 'identificationModule': {'nctId': 'NCT07472257', 'briefTitle': 'The Longer, the Better? Investigating the Effect of Prolonged Acoustic Stimulation on Brief Acoustic Tinnitus Suppression', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Effects of Acoustic Stimulation Techniques on Tinnitus', 'orgStudyIdInfo': {'id': '17-819-101'}, 'secondaryIdInfos': [{'id': 'agreement number 722046', 'type': 'OTHER_GRANT', 'domain': "European Union's Horizon 2020 research and innovation program under the Marie SklodowskaCurie grant"}, {'id': "Swiss National Fund 'Early Pos", 'type': 'OTHER_GRANT', 'domain': 'P2ZHP1 174967'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Acoustic stimulation with individual best stimulus - 20 minutes', 'description': 'Acoustic stimulation - 20 minutes', 'interventionNames': ['Other: Acoustic Stimulation - 20 minutes']}, {'type': 'OTHER', 'label': 'Acoustic stimulation with individual best stimulus - 3 minutes', 'description': 'Acoustic stimulation - 3 minutes', 'interventionNames': ['Other: Acoustic stimulation - 3 minutes']}], 'interventions': [{'name': 'Acoustic Stimulation - 20 minutes', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Acoustic stimulation with individual best stimulus - 20 minutes']}, {'name': 'Acoustic stimulation - 3 minutes', 'type': 'OTHER', 'description': "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,", 'armGroupLabels': ['Acoustic stimulation with individual best stimulus - 3 minutes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not relevant'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Berthold Langguth', 'investigatorFullName': 'Berthold Langguth, MD, Ph.D.', 'investigatorAffiliation': 'University of Regensburg'}}}}