The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (Aktin)

Investigation of the antinitus patch in patients with manifested tinnitus.

  1. Tinnitus Talk
    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


    Estimated Enrollment: 16
    Study Start Date: October 2010
    Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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