NCT01226108

The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Akloma Bioscience AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	Patch	One patch per day, Duration: three weeks, Administration: behind the ear \--------------------------------------------------------------------------------

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-08-01
• First posted: 2010-10-21
• Last updated: 2011-09-26

Locations

1 site across 1 country: Sweden