TinnitusNCT02974543
Auditory-somatosensory Stimulation to Alleviate Tinnitus
A study testing Active Treatment: Bimodal auditory-somatosensory stimulation in people with Tinnitus, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Active Treatment: Bimodal auditory-somatosensory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
- Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
- Able to modulate their tinnitus with a somatic maneuver
- BothersomeTinnitus.
Who cannot join
- No participation in a tinnitus treatment regimen within the past four weeks
- Retrocochlear pathology/ VIIIth nerve lesion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Kresge Hearing Research Institute
Ann Arbor, Michigan, 48109
About this study
Official title: Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.
Read the detailed description
This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.
The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.
- Conditions
- Tinnitus
- Being tested
- Sham Treatment: unimodal auditory stimulation, Active Treatment: Bimodal auditory-somatosensory stimulation
- Keywords
- tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Treatment: unimodal auditory stimulationDevice
All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
Active Treatment: Bimodal auditory-somatosensory stimulationDevice
Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.
| Study group | Role | What they receive |
|---|---|---|
| Sham 1st (Auditory only) then Active (Bimodal) | Other | To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
During active treatment, the device will deliver electric somatosensory and auditory stimulation. Receives: Device: Sham Treatment: unimodal auditory stimulation; Device: Active Treatment: Bimodal auditory-somatosensory stimulation |
| Active (Bimodal) then Sham (Auditory only) | Other | During active treatment, the device will deliver electric somatosensory and auditory stimulation.
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Receives: Device: Sham Treatment: unimodal auditory stimulation; Device: Active Treatment: Bimodal auditory-somatosensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.
Measured: Four weeks on treatment (or sham)
Change in Tinnitus Loudness as Assessed by TinnTester
Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.
Measured: 4 weeks on treatment (or sham)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Wallace H Coulter Center for Translational Research
- Responsible party
- Principal investigator, Susan E. Shore, University of Michigan
- Investigators
- Susan Shore, Ph.D, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974543
- Sponsor's protocol ID
- HUM00088432
- Status last verified
- Apr 2017
- First submitted
- 14 Nov 2016
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
- ClinicalTrials.gov ID
- NCT02974543
- Acronym / sponsor ID
- HUM00088432
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Wallace H Coulter Center for Translational Research
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.
Detailed description
This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.
The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham 1st (Auditory only) then Active (Bimodal) | Other | Device: Sham Treatment: unimodal auditory stimulation, Device: Active Treatment: Bimodal auditory-somatosensory stimulationTo mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. |
| Active (Bimodal) then Sham (Auditory only) | Other | Device: Sham Treatment: unimodal auditory stimulation, Device: Active Treatment: Bimodal auditory-somatosensory stimulationDuring active treatment, the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
- Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
- Able to modulate their tinnitus with a somatic maneuver
- BothersomeTinnitus.
Key exclusion criteria (2 listed)
- No participation in a tinnitus treatment regimen within the past four weeks
- Retrocochlear pathology/ VIIIth nerve lesion
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 |
|---|---|---|
| Sham Treatment: unimodal auditory stimulationAll subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. | Device | Active (Bimodal) then Sham (Auditory only), Sham 1st (Auditory only) then Active (Bimodal) |
| Active Treatment: Bimodal auditory-somatosensory stimulationSomatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone. | Device | Active (Bimodal) then Sham (Auditory only), Sham 1st (Auditory only) then Active (Bimodal) |
Primary outcome
Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
Time frame: Four weeks on treatment (or sham)
Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.
Change in Tinnitus Loudness as Assessed by TinnTester
Time frame: 4 weeks on treatment (or sham)
Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Susan Shore, Ph.D principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Treatment: Bimodal auditory-somatosensory stimulation in people with Tinnitus, run by University of Michigan 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 2 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 17 May 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?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline (time frame: Four weeks on treatment (or sham)). 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 17 May 2017.