Tinnitus and Treatment With umPEA-LUT

NCT06718452 | Not Yet Recruiting

• 2 other identifiers: UniLINK2026University LINK
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus; Neuroinflammation

Keywords

Tinnitus; Neuroinflammation; Palmitoyetanolamide; Luteolin; Ultramicronized; Vascular; Central; Peripheral; Auditory cortex; Inner ear

Outcome Measures

Primary Outcomes (1)

• Tinnitus

  Tinnitus questionnaire

  At Enrollement, after 3 months of treatment, after 6 months of treatment (end of the therapy)

Secondary Outcomes (1)

• Auditory test

  Enrollement (T0) and after 6 months (end of the therapy)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients in this group will be treated using placebo

Dietary Supplement: Placebo

Ultramicronized PEALUT Double dose

EXPERIMENTAL

umPEALUT 2 sachet/day every day for 60 days

Dietary Supplement: PEA-LUT 2 sachet day

TREATMENT 2

EXPERIMENTAL

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

Combination Product: umPEALUT + Rutin + 5 hTp

Interventions

PEA-LUT 2 sachet day DIETARY_SUPPLEMENT

1 sachet two times a day to be sublingually absorbed

Ultramicronized PEALUT Double dose

umPEALUT + Rutin + 5 hTp 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

TREATMENT 2

Placebo DIETARY_SUPPLEMENT

Same administration of PEA-LUT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Universita degli Studi di Napoli Federico: collaborator

Study Sites (1)

Vanvitelli ENT department

Naples, Campania, 80138, Italy

Location

Related Publications (22)

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MeSH Terms

Conditions

Tinnitus; Neuroinflammatory Diseases

Interventions

Rutin; 5-Hydroxytryptophan

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Arianna Di Stadio, MD, PhD, MSc

  Vanvitelli University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor definite time

Model Details: Longitudinal study

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

IT (1)