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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226108
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
Akloma Bioscience AB

Brief Summary:


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.


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

Condition or disease Intervention/treatment Phase
Tinnitus Device: Patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
Study Start Date : October 2010
Actual Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: antinitus patch
One patch per day, Duration: three weeks, Administration: behind the ear
Device: Patch

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


Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 weeks ]
  2. Tinnitus severity questionnaire score as a measure of efficacy [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01226108

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Sickla ÖNH-center, Atlashuset Planiavägen 5
Nacka, Sweden, 131 34
Sponsors and Collaborators
Akloma Bioscience AB
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Principal Investigator: Peter Åhnblad Sickla ÖNH-center / Supramed AB
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Responsible Party: Akloma Bioscience AB Identifier: NCT01226108    
Other Study ID Numbers: Aktin study
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases