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Active Not Recruiting
NCT05737888
Physiological Regulation of Chronic Tinnitus
Conditions: Tinnitus
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 90
Sponsor: Wyss Center for Bio and Neuroengineering
Location: Switzerland
Summary
The present project involves research on humans with the aim to characterize the reduction of chronic, continuous, non-pulsatile and debilitating tinnitus in humans by comparing neurofeedback (fMRI or EEG) to the current gold standard behavioral cognitive therapy.
Eligibility Criteria
Inclusion Criteria:Age between 18 to 80 yearsTinnitus Handicap Inventory ≥ 48Chronic, persistent, non-pulsatile tinnitus for minimum 6 monthsFunctional hearingNormal inner ear structure assessment using an ear microscope, normal tympanic membrane mobilityParticipant willing, able and available to participate in the entire research, including completion of questionnaires and traveling to research sites for the duration of the trialExclusion Criteria:Contraindication to MRI (e.g.
non compatible cochlear implant, pacemaker, deep brain stimulation)Conductive hearing loss exceeding 20 dB at two or more frequenciesKnown diagnoses causing tinnitus or hearing loss:Known systemic disease (vestibular schwannoma, endolymphatic hydrops)Lesion in central nervous system, including history of severe cranio-cerebral traumaAcute ear canal or middle ear inflammation or effusionSignificant neurologic disease, psychiatric disease, substance abuse or acute allergic diseaseOngoing medication that is known to treat, influence, or cause tinnitus (e.g.
high-dose aspirin, quinidine, aminoglycosides)Ongoing or recent (completed since less than 4 weeks) tinnitus therapy (e.g.
tinnitus maskers, acupuncture)Participation in competitive or pharmacological studyPregnant woman
Source: ClinicalTrials.gov (NCT05737888). StuddyBuddy aggregates publicly available trial information.