TinnitusNCT02717065
Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
A study testing Tone and Video in people with Tinnitus, run by University of Minnesota at 1 site in United States.
Trial summary
Characterizing the nature and severity of tinnitus in individuals presents a particular challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. Different methods are used to measure each parameter. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Tone and Video
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2017to Jan 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have subjective, non-pulsatile and bothersome tinnitus
- Ability to give informed consent and understand study objectives and procedures in English
- Willing and able to understand and comply with all study-related procedures
- Will not start any new tinnitus treatment during the study
Who cannot join
- Substantial hearing loss or hyperacusis that may interfere with the study
- Medical history of other ear or brain disorders
- Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety)
- Any handicap that prevents the subject from reliably performing the tests, such as blindness.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Nils Hasselmo Hall, 6-105
Minneapolis, Minnesota, 55455
About this study
Characterizing the nature and severity of tinnitus in individuals presents a particular challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. Different methods are used to measure each parameter. Loudness is measured using a technique called "minimum masking," in which the subject is presented with a broadband white noise and asked to adjust the loudness level until they can no longer hear their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These questionnaires assess the perceived severity of the tinnitus and the effect on everyday activities and quality of life. A visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. In the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual.
The second part will look at the influence of context-specific visual information on auditory perception. This involves watching silent videos of a person speaking, with and without an additional tone designed to match the subject's tinnitus. The effect of this audiovisual feedback on the subject's perception of tinnitus will be assessed using a subjective rating scale and the minimum masking task.
Read the detailed description
This study is not specifically seeking to treat tinnitus, but is designed to investigate various parameters that can alter the tinnitus percept. Findings from this study will help identify parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.
- Conditions
- Tinnitus
- Being tested
- Tone, Video
- Keywords
- Neuromodulation, Noninvasive, Plasticity, Hearing, Hyperacusis
- Medical subject headings
- Tinnitus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToneOther
Band-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones.
VideoOther
Silent video recording of a person speaking or a still face with an expanding circle over the mouth presented on a computer or tablet screen.
| Study group | Role | What they receive |
|---|---|---|
| Characterization, Audiovisual | Experimental | Characterization: Tinnitus characterization tools (Minimal Masking Level, Tinnitus Functional Index, Tinnitus Handicap Inventory, and Subjective rating scale) are assessed in an individual over time to determine baseline variability.
Audiovisual: The individual will watch a series of silent videos of a person speaking, both with and without a tone matched to their tinnitus as well as videos of a still face with and without the matched tone. Receives: Other: Tone; Other: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minimal Masking Level
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Measured: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
Change in Tinnitus Rating (0-10, 10 being worst)
the subject rates the disturbance or bothering nature of the tinnitus.
Measured: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Secondary outcomes (3)
Change in Tinnitus Functional Index Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Measured: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Handicap Inventory Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Measured: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Subjective Description
The subject describes the quality, characteristics, and bothering nature of the tinnitus.
Measured: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Personnel and funding was no longer available
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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert Lim, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717065
- Sponsor's protocol ID
- 1512M81434
- Status last verified
- Sep 2017
- First submitted
- 17 Mar 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception
- ClinicalTrials.gov ID
- NCT02717065
- Acronym / sponsor ID
- 1512M81434
- Conditions
- Tinnitus
- Keywords
- Neuromodulation, Noninvasive, Plasticity, Hearing, Hyperacusis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Personnel and funding was no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 23 Mar 2016 (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.
Characterizing the nature and severity of tinnitus in individuals presents a particular challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. Different methods are used to measure each parameter. Loudness is measured using a technique called "minimum masking," in which the subject is presented with a broadband white noise and asked to adjust the loudness level until they can no longer hear their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These questionnaires assess the perceived severity of the tinnitus and the effect on everyday activities and quality of life. A visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. In the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual.
The second part will look at the influence of context-specific visual information on auditory perception. This involves watching silent videos of a person speaking, with and without an additional tone designed to match the subject's tinnitus. The effect of this audiovisual feedback on the subject's perception of tinnitus will be assessed using a subjective rating scale and the minimum masking task.
Detailed description
This study is not specifically seeking to treat tinnitus, but is designed to investigate various parameters that can alter the tinnitus percept. Findings from this study will help identify parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Characterization, Audiovisual | Experimental | Other: Tone, Other: VideoCharacterization: Tinnitus characterization tools (Minimal Masking Level, Tinnitus Functional Index, Tinnitus Handicap Inventory, and Subjective rating scale) are assessed in an individual over time to determine baseline variability. Audiovisual: The individual will watch a series of silent videos of a person speaking, both with and without a tone matched to their tinnitus as well as videos of a still face with and without the matched tone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have subjective, non-pulsatile and bothersome tinnitus
- Ability to give informed consent and understand study objectives and procedures in English
- Willing and able to understand and comply with all study-related procedures
- Will not start any new tinnitus treatment during the study
Key exclusion criteria (4 listed)
- Substantial hearing loss or hyperacusis that may interfere with the study
- Medical history of other ear or brain disorders
- Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety)
- Any handicap that prevents the subject from reliably performing the tests, such as blindness.
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 |
|---|---|---|
| ToneBand-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones. | Other | Characterization, Audiovisual |
| VideoSilent video recording of a person speaking or a still face with an expanding circle over the mouth presented on a computer or tablet screen. | Other | Characterization, Audiovisual |
Primary outcome
Change in Minimal Masking Level
Time frame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Change in Tinnitus Rating (0-10, 10 being worst)
Time frame: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
the subject rates the disturbance or bothering nature of the tinnitus.
3 secondary outcomes
Change in Tinnitus Functional Index Questionnaire Score
Time frame: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Handicap Inventory Questionnaire Score
Time frame: Change from baseline score at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Subjective Description
Time frame: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Hubert Lim, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tone and Video in people with Tinnitus, run by University of Minnesota at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Sep 2017. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Minimal Masking Level (time frame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm.). 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 14 Sep 2017.