Tinnitus
Conditions
Brief summary
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
Interventions
DEVICEPatch
One patch per day, Duration: three weeks, Administration: behind the ear \--------------------------------------------------------------------------------
Sponsors
Akloma Bioscience AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Sweden
Outcome results
None listed