Tinnitus and Treatment With umPEA-LUT (TiniPEA)

February 3, 2026 updated by: Arianna Di Stadio, University of Campania Luigi Vanvitelli

Treatment of Tinnitus Targeting Neuroinflammation. umPEALUT as Possible Option

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Naples, Campania, Italy, 80138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients in this group will be treated using placebo
Dietary supplement: Placebo
Same administration of PEA-LUT
Experimental: Ultramicronized PEALUT Double dose
umPEALUT 2 sachet/day every day for 60 days
Dietary supplement: PEA-LUT 2 sachet day
1 sachet two times a day to be sublingually absorbed
Experimental: TREATMENT 2
umPEALUT 2 sachets day + 120 mg Rutin +100 mg 5 hTp
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus
Time Frame: At Enrollement, after 3 months of treatment, after 6 months of treatment (end of the therapy)
Tinnitus questionnaire
At Enrollement, after 3 months of treatment, after 6 months of treatment (end of the therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory test
Time Frame: Enrollement (T0) and after 6 months (end of the therapy)
Pure Tone Auditory test
Enrollement (T0) and after 6 months (end of the therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Collaborators

Universita degli Studi di Napoli Federico

Investigators

  • Study Chair: Arianna Di Stadio, MD, PhD, MSc, Vanvitelli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniLINK2026
  • University LINK (Other Identifier: Public Institution)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are thinking about put everything in a repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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