TinnitusAktinNCT01226108
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
A study testing Patch in people with Tinnitus, run by Akloma Bioscience AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
OBJECTIVES:
Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
Read more
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
- Being tested
- Patch
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatchDevice
One patch per day, Duration: three weeks, Administration: behind the ear
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| antinitus patch | Active comparator | One patch per day, Duration: three weeks, Administration: behind the ear Receives: Device: Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 7 weeks
Tinnitus severity questionnaire score as a measure of efficacy
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akloma Bioscience AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Åhnblad, Principal investigator, Sickla ÖNH-center / Supramed AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226108
- Sponsor's protocol ID
- Aktin study
- Acronym
- Aktin
- Status last verified
- Sep 2011
- First submitted
- 20 Oct 2010
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
- ClinicalTrials.gov ID
- NCT01226108
- Acronym / sponsor ID
- Aktin / Aktin study
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Akloma Bioscience ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antinitus patch | Active comparator | Device: PatchOne patch per day, Duration: three weeks, Administration: behind the ear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatchOne patch per day, Duration: three weeks, Administration: behind the ear -------------------------------------------------------------------------------- | Device | antinitus patch |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Åhnblad principal investigator
Sickla ÖNH-center / Supramed AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch in people with Tinnitus, run by Akloma Bioscience AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.