Tinnitus and Treatment With umPEA-LUT

NCT ID: NCT06718452

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-20
• Study Completion Date: 2026-12-31

Brief Summary

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.

Tinnitus 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.

Tinnitus 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.

In addition to the overmentioned medical causes, tinnitus can also be sign of psychiatric/psychological 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/stressful 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 .

Stress 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.

The effects of inflammation on the hair cells are identifiable only through electrophysiological studies or from the temporal bone.

Keeping 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/abolishing noise.

umPeaLut 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.

Although 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.

This study aims at evaluating the efficacy of umPEALUT as a therapeutic treatment of tinnitus in a sample of adults.

Detailed Description

Longitudinal study on 100 patients

Patients between 18 and 70 years of age, not affected by systemic disorders (hypertension, diabetes, neurological disorders, previous stroke) or known psychological/psychiatric disorders will be included.

The patients will be evaluated at three observation times: T0 before treatment at the time of enrollment, T3 after 3 months and T6 after six months of treatment.

All patients, at each check-point will be screened as following: 1) three questionnaire to evaluate Tinnitus and 2) audiometric examination and acuphenometry.

Patients will be randomized into three groups, one group (CONTROL) that will use placebo, one (TREATMENT1 ) group that will use umPEALUT 2 sachets for day, and the other group (TREATMENT 2) umPEALUT 2 sachets par day combined to 120 mg of Rutin and 100 of 5-hTP.

EXPECTED RESULTS

Patients treated with umPEALUT compared to the control group will present an improvement of the symptom due to the anti-ROS action of luteolin and the neuro-immuno-modulating action of PEA. However the combination of umPEALUt with rutin and 5hTp will have better results than treatment with umPEALUT alone and control.

The changes induced by the treatment will be identifiable through the improvement of the symptom (responses to the questionnaire) and the changes in the subjective auditory test.

Specifically, patients in group 1 will present better final values than group 2, although group 2 will, however, present improvements compared to the control.

Conditions

Tinnitus; Neuroinflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Patients in this group will be treated using placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Same administration of PEA-LUT

Ultramicronized PEALUT Double dose

umPEALUT 2 sachet/day every day for 60 days

Group Type: EXPERIMENTAL

PEA-LUT 2 sachet day

Intervention Type: DIETARY_SUPPLEMENT

1 sachet two times a day to be sublingually absorbed

TREATMENT 2

umPEALUT 2 sachets day + 120 mg Rutin +100 mg 5 hTp

Group Type: EXPERIMENTAL

umPEALUT + Rutin + 5 hTp

Intervention Type: COMBINATION_PRODUCT

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

Interventions

PEA-LUT 2 sachet day

1 sachet two times a day to be sublingually absorbed

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Same administration of PEA-LUT

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Patients with tinnitus not under treatment at least for 30 days

Exclusion Criteria

• Stroke in the last year
• Uncontrolled diabetes,
• Uncontrolled hypertension,
• Severe psychiatric disorders,
• Severe cognitive decline,
• Previous surgery of the brain or audio-vestibular nerves

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universita degli Studi di Napoli Federico

UNKNOWN

Sponsor Role: collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Arianna Di Stadio

Associate Professor definite time

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arianna Di Stadio, MD, PhD, MSc

Role: STUDY_CHAIR

Vanvitelli University

Locations

Vanvitelli ENT department

Naples, Campania, Italy

Countries

Italy

Facility Contacts

Giovanni Motta, MD

Role: primary

giovannimotta95@yahoo.it

081 566 6432

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Other Identifiers

University LINK

Identifier Type: OTHER

Identifier Source: secondary_id

UniLINK2026

Identifier Type: -

Identifier Source: org_study_id