Tinnitus
Conditions
Keywords
tinnitus
Brief 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.
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.
Interventions
DEVICESham Treatment: unimodal auditory stimulation
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.
DEVICEActive Treatment: Bimodal auditory-somatosensory stimulation
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.
Sponsors
Wallace H Coulter Center for Translational Research
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology. 2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies. 3. Able to modulate their tinnitus with a somatic maneuver 4. BothersomeTinnitus.
Exclusion criteria
* No participation in a tinnitus treatment regimen within the past four weeks * Retrocochlear pathology/ VIIIth nerve lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
14 participants consented to the study, but were screened out of allocation to either arm for excess hearing loss, lack of somatosensory modulation, or unwillingness to participate (largely due to time committments/availability).
Participants by arm
| Arm | Count |
|---|---|
| Active 1st (Bimodal) Then Sham (Auditory Only) 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. Sham Treatment: unimodal auditory stimulation: 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 stimulation: 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, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum. | 10 |
| Sham 1st (Auditory Only) Then Active (Bimodal) 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. Sham Treatment: unimodal auditory stimulation: 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 stimulation: 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, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Active 1st (Bimodal) Then Sham (Auditory Only) | Total | Sham 1st (Auditory Only) Then Active (Bimodal) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 19 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
| Tinnitus Functional Index (TFI) | 34.88 units on a scale STANDARD_DEVIATION 16.7 | 31.78 units on a scale STANDARD_DEVIATION 16.7 | 26.66 units on a scale STANDARD_DEVIATION 14.78 |
| Tinnitus Loudness | 58.99 dB STANDARD_DEVIATION 14.77 | 54.42 dB STANDARD_DEVIATION 14.77 | 49.85 dB STANDARD_DEVIATION 18.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Four weeks on treatment (or sham)
Population: First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Before Sham | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | -10.08 units on a scale | Standard Deviation 6.79 |
| Washout After Active | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | -5.40 units on a scale | Standard Deviation 4.11 |
| Sham After Active | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | 0.95 units on a scale | Standard Deviation 10.32 |
| Sham Before Active | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | -4.34 units on a scale | Standard Deviation 4.11 |
| Washout After Sham | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | -2.24 units on a scale | Standard Deviation 4.58 |
| Active After Sham | Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | -5.27 units on a scale | Standard Deviation 6.46 |
p-value: <0.05Mixed Models Analysis
Primary
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.
Time frame: 4 weeks on treatment (or sham)
Population: First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Before Sham | Change in Tinnitus Loudness as Assessed by TinnTester | -8.25 dB | Standard Deviation 9.69 |
| Washout After Active | Change in Tinnitus Loudness as Assessed by TinnTester | -1.52 dB | Standard Deviation 7.16 |
| Sham After Active | Change in Tinnitus Loudness as Assessed by TinnTester | -3.17 dB | Standard Deviation 5.02 |
| Sham Before Active | Change in Tinnitus Loudness as Assessed by TinnTester | -3.34 dB | Standard Deviation 4.5 |
| Washout After Sham | Change in Tinnitus Loudness as Assessed by TinnTester | -1.67 dB | Standard Deviation 3.98 |
| Active After Sham | Change in Tinnitus Loudness as Assessed by TinnTester | -7.85 dB | Standard Deviation 8.79 |
p-value: <0.05Mixed Models Analysis