The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

Akloma Bioscience AB16 enrolled

Overview

OBJECTIVES: Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects. Secondary Objectives The secondary objective will be to: To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality. METHODOLOGY Study Design: An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus. Treatment Duration: 1 patch per day for 3 weeks Primary Endpoint: Tinnitus severity questionnaire (TSQ) Performance Parameters: Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus annoyance. Quality of life and sleep quality Safety Parameters: Adverse Reactions

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tinnitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults of both sexes \> 18 years of age * Signed informed consent * Patients who have suffered from tinnitus for ≥ 4 weeks before study entry * Manifested tinnitus grade II or above on the Klockhoff-Lindblom tinnitus severity grading scale. * Tinnitus score of 5 or above (numerical rating scale for tinnitus annoyance) * Pure tone averages better than 40 dB in the worse hearing ear. Exclusion Criteria: * Pregnant or lactating women * Malignancy or other serious medical conditions * Skin disease * Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices. * Severe psychiatric disorder * Serious suicidal risk * Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before study start. * Patients with untreated high blood pressure ≥140/90 mmHg * Other tinnitus treatment within 6 weeks before study entry. * Previous use of the Antinitus patch * Known allergy or sensitivity to any of the compounds in the Antinitus or the placebo patches.

Outcomes

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 7 weeks

Tinnitus severity questionnaire score as a measure of efficacy

Time frame: 3 weeks