Completed

NCT Number: NCT01226108

The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

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

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sickla ÖNH-center, Atlashuset Planiavägen 5

Nacka, 131 34, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patch

Device

One patch per day, Duration: three weeks, Administration: behind the ear

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Primary outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 7 weeks
Tinnitus severity questionnaire score as a measure of efficacy

Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Akloma Bioscience AB

Industry

Registry information

Official study title

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

Acronym: Aktin

Important dates

Study start: 2010
Primary completion: 2011
First posted: Oct 21, 2010
Registry last updated: Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed