Tinnitus Clinical Trial
Official title:
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
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
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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