The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

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

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.