The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
NCT ID: NCT01226108
Last Updated: 2011-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
antinitus patch
One patch per day, Duration: three weeks, Administration: behind the ear
Patch
One patch per day, Duration: three weeks, Administration: behind the ear
\--------------------------------------------------------------------------------
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Patch
One patch per day, Duration: three weeks, Administration: behind the ear
\--------------------------------------------------------------------------------
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akloma Bioscience AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Åhnblad
Role: PRINCIPAL_INVESTIGATOR
Sickla ÖNH-center / Supramed AB
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sickla ÖNH-center, Atlashuset Planiavägen 5
Nacka, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Aktin study
Identifier Type: -
Identifier Source: org_study_id