[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571299":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":31,"locations":45,"responsibleParty":65,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":31,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":103,"whyStopped":31,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Campania Luigi Vanvitelli","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Patients in this group will be treated using placebo",[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Ultramicronized PEALUT Double dose","EXPERIMENTAL","umPEALUT 2 sachet\u002Fday every day for 60 days",[19],"Dietary Supplement: PEA-LUT 2 sachet day",{"label":21,"type":16,"description":22,"interventionNames":23},"TREATMENT 2","umPEALUT 2 sachets day + 120 mg Rutin +100 mg 5 hTp",[24],"Combination Product: umPEALUT + Rutin + 5 hTp",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","PEA-LUT 2 sachet day","1 sachet two times a day to be sublingually absorbed",[15],null,{"type":27,"name":9,"description":33,"armGroupLabels":34,"otherNames":31},"Same administration of PEA-LUT",[9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"COMBINATION_PRODUCT","umPEALUT + Rutin + 5 hTp","People in this group will be treated by 2 sachets par day of umPEALUT associated to 120 mg of rutin and 100 mg of 5 hTp",[21],[41],{"name":42,"affiliation":43,"role":44},"Arianna Di Stadio, MD, PhD, MSc","Vanvitelli University","STUDY_CHAIR",[46],{"facility":47,"status":31,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Vanvitelli ENT department","Naples","Campania","80138","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],14.26811,40.85216,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":63,"phoneExt":31,"email":64},"Giovanni Motta, MD","CONTACT","081 566 6432","giovannimotta95@yahoo.it",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Arianna Di Stadio","Associate Professor definite time",[70],{"name":71,"class":6},"Federico II University","100571299","tinnitus-and-treatment-with-umpea-lut-100571299",false,"NCT06718452","Tinnitus and Treatment With umPEA-LUT","Treatment of Tinnitus Targeting Neuroinflammation. umPEALUT as Possible Option","TiniPEA","Inclusion Criteria:\n\n\\- Patients with tinnitus not under treatment at least for 30 days\n\nExclusion Criteria:\n\n* Stroke in the last year\n* Uncontrolled diabetes,\n* Uncontrolled hypertension,\n* Severe psychiatric disorders,\n* Severe cognitive decline,\n* Previous surgery of the brain or audio-vestibular nerves",true,"ALL","18 Years","70 Years",{"count":85,"type":86},100,"ESTIMATED","INTERVENTIONAL",[89],"NA","Tinnitus can have different causes. From a peripheral point of view, the sensation of hearing a not present sound can be indicative of damage in the cells of the cochlea. Damage at this level can arise from traumatic, vascular, toxic origins or be caused by systemic pathologies. However, all the previous causes have a common denominator, the presence of reactive oxygen species (ROS), in the cochlea which determines the damage and the consequent death of the hair cells into the ear. The sound (tinnitus) that the patient perceives is generated by the spontaneous movement of the cilia of the hair cells; this phenomenon arises when these cells begin to be damaged.\n\nTinnitus can be also caused by a retrocochlear disorder such as damage of the auditory nerve (inflammatory and tumor cause). In case of an inflammatory origin, the factors released during inflammation can locally damage the nerves and spread into the cochlea destroying the hair cells.\n\nTinnitus can also originate from damage in the central auditory pathway. In this case, the problem persistent. It is important to keep in mind that although initially the tinnitus may originate from a damage inside the cochlea, after 6 months of persistence chronicizes causing an activation (without stimulus) of the upper auditory areas. This zone of \"hypersensitivity\" is therefore responsible for chronic tinnitus.\n\nIn addition to the overmentioned medical causes, tinnitus can also be sign of psychiatric\u002Fpsychological disorders, in those cases in whom there is an involvement of the hypothalamus, as showed by neuropsychological studies. Tinnitus can be temporary and disappear spontaneously or, in the most of cases, be persistent and extremely annoying\u002Fstressful for the patient. At night in particular, in the absence of noise, the patient suffers more the presence of this ghost sound, which in some occasions prevents sleep. Insomnia negatively impacts on tinnitus increasing its duration and intensity, thus establishing a perpetual cycle of stress into the brain. The latter phenomenon worses and chronicizes the symptom .\n\nStress causes inflammation with ROS increase, which can affect both the peripheral and central auditory pathways. Recently, it has been shown that tinnitus can be a symptom of neuro-inflammatory pathologies such as, for example, Multiple Sclerosis.\n\nThe effects of inflammation on the hair cells are identifiable only through electrophysiological studies or from the temporal bone.\n\nKeeping on mind inflammation and neuro-inflammation and considering the exchange between cerebrospinal fluid and perilymph , we speculate that the use of a molecule capable of reducing inflammation and modulating the action of mast cells and microglia, could be an effective tool to resolve tinnitus; moreover, thanks to its powerful action at the level of neuro-inflammation, it could reduce the hyper-activity in the upper auditory tracts, thus reducing\u002Fabolishing noise.\n\numPeaLut combines palmitoylethanolamide, which modulates the activity of mast cells, macrophages and microglia and luteolin, a bioflanoid extracted from fruits with anti-oxidant properties, able to improve microcirculation. Because the alterations of the ear microcirculation can be an additional cause of tinnitus, we believe that luteolin content can be an ulterior benefit.\n\nAlthough various attempts have been made to use a mono-molecule, recent studies have shown that combination of several elements could reduce tinnitus ; PeaLut, in its ultra-micronized form with high bioavailability, could be the perfect solution.\n\nThis study aims at evaluating the efficacy of umPEALUT as a therapeutic treatment of tinnitus in a sample of adults.",[92,93],"Tinnitus","Neuroinflammation",[92,93,95,96,97,98,99,100,101,102],"Palmitoyetanolamide","Luteolin","Ultramicronized","Vascular","Central","Peripheral","Auditory cortex","Inner ear","NOT_YET_RECRUITING","2026-02-03",{"date":106,"type":107},"2026-02-06","ACTUAL",{"date":109,"type":86},"2026-04-20",{"date":111,"type":86},"2026-12-31",{"name":5,"class":6},1]