The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

Study Overview
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Brief Summary
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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

Official Title
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The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: antinitus patch<br>One patch per day, Duration: three weeks, Administration: behind the ear | Device: Patch<br>* One patch per day, Duration: three weeks, Administration: behind the ear --------------------------------------------------------------------------------<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 7 weeks | 
| Tinnitus severity questionnaire score as a measure of efficacy |  | 3 weeks |