Tinnitus
Conditions
Keywords
Audiology, Otolaryngology, Mindfulness Based Stress Reduction (MBSR), auricular branch of vagus nerve, neuromodulation, transcutaneous stimulation
Brief summary
This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus. Participants will be randomly assigned to either an active auricular stimulation device group or a sham-control group.Both groups will also undergo virtual Mindfulness-Based Stress Reduction(MBSR) over 8 weeks to promote tinnitus bother reduction, and general well-being. Outcome measures will be assessed at baseline, end of intervention, and at 1-month post-intervention.
Detailed description
Adults experiencing moderate to severe tinnitus have significant impairment in their quality of life. While Cognitive Behavioral Therapy (CBT) is the most effective treatment for tinnitus, its accessibility is limited. Alternative treatment options such as masking pose significant risks and have varying success rates in achieving tinnitus cessation. Given these limitations and risks, there is a need to explore alternative treatment options for tinnitus that are both effective and easily accessible. Transcutaneous electrical stimulation of the vagus nerve has been explored as a treatment option for tinnitus using different study designs with varying response rate. In contrary, this pilot study will provide valuable insights and preliminary evidence for the effectiveness of transcutaneous stimulation of the auricular branch of the vagus nerve (TABVN-stim) utilizing a novel device that produces vibrational stimulation mimicking physiological sensory input to the ABVN. This research provides preliminary evidence for a potentially safe, non-invasive, and easily applicable treatment option for those suffering from chronic bothersome tinnitus, ultimately improving their quality of life.
Interventions
DEVICEVibrational stimulation
The auricular stimulation device produces continuous vibrational stimulation directly to the conchae of the auricle. It is designed to stimulate the vagus nerve for neuromodulation to treat a variety of clinical indications. The system includes a pulse generator and an ear electrode device. Participants will use a vibration motor in a custom-created soft plastic clip for the left ear. Each participant will receive their own device by mail, which they will wear during the the 30 minutes mindfulness exercise portion of the 2-hour MBSR group sessions. Additionally, they will wear the devices during the 20-minute at-home MBSR activities for the remaining six days of the week, totaling 120 minutes. The total expected duration of device usage per week will be 2.5 hours or 150 minutes.
DEVICESham
The sham device looks and is used identically to the auricular stimulation device, but does not produce vibrational stimulation. There will be no difference in the usage directions of the sham device compared to the stimulation device. Each participant will receive their own device by mail, which they will wear during the 30 minutes mindfulness exercise portion of the 2-hour MBSR group sessions. Additionally, they will wear the devices during the 20-minute at-home MBSR activities for the remaining six days of the week, totaling 120 minutes. The total expected duration of device usage per week will be 2.5 hours or 150 minutes.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participants, and research team will be unaware of whether device A or B corresponds to the stimulation or sham device during the study
Intervention model description
This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Ability to read, write, speak, and understand English * Bothersome tinnitus with initial TSSF score greater than 40 on screening * Available for the entire period of the study including one month follow-up after completion of 8-week intervention period * Access to internet-connected device(s) such as phone, tablet, or laptop with a camera
Exclusion criteria
* Age\>70 * Pregnant or planning to become pregnant during the study period * Previous participation in an auricular stimulation trial * Currently on active treatment for tinnitus * Have cochlear implant or other device that impedes usage of auricular stimulation device * Tinnitus related to ear surgery, Meniere's disease, ear infections, or other ear pathology * Substance abuse * Unstable psychiatric disorders * Patient Health Questionnaire (PHQ-9) score greater than 9 History of brain surgery * History of traumatic brain injury * History of bradycardia or bradyarythmias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder proportion | Week 9 | The responder proportion will be defined as number of participants with \>12- point change in Tinnitus Severity Short Form \[TSSF\] score at the end of treatment compared to baseline, divided by the total number of participants in each group. TSSF score ranges from 0 (mild) to 100 (severe) The responder proportion will be compared between the active and sham group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of adequate device users | Week 9 | Feasibility of the auricular device will be assessed by recording the duration of device usage each week, summed over 8 weeks, and calculated as a percentage of the total expected usage which is 2.5 hours(per week) x 8 for each participant. Participants with \>80% device usage will be defined as adequate device users. The proportion of adequate users will be compared between the stimulation and sham groups |
| Adverse events | Week 9, and 13 | The summary of reported adverse events after 8-weeks of the study period, and after 4 weeks post-intervention will be compared between stimulation and sham groups. |
| Proportion of participants reporting improvement on CGI-I | Week 9 and 13 | Participants will rate their perception of their response to tinnitus treatment using the CGI-I scale. The proportion of participants reporting improvement will be calculated as the number of participants with a CGI-I score ≤3 (defined as reporting improvement) divided by the total number of participants in each group. The proportion will be compared between the active and sham group after 8 weeks of intervention, and at 4 weeks post-intervention. Clinical Global Impression of Improvement Scale: The CGI-I scale is a self-reported measure widely used in previous studies and adapted from validated scales used in psychiatric studies. Participants will answer the question, Overall, how do you rate your response to tinnitus treatment? It offers 7 response options ranging from: 1-Very Much Improved, 2-Much Improved, 3-Minimally Improved, 4-No Change, 5-Minimally Worse, 6-Much Worse, to 7-Very Much Worse. |
| Change in CGI-S | Week 9, and 13 | The change in CGI-S score from baseline after 8 weeks of intervention and 4 weeks post intervention will be compared between the active and sham group. Clinical Global Impression of Severity (CGI-S) Scale: The CGI-S scale assesses the perceived severity problem level of tinnitus symptoms, with 5 response options ranging from 1-Not bothered, 2-Bothered a little, but not much, 3-Bothered more than a little, but not a lot, 4-Bothered a lot, to 5-Extremely bothered. It poses the question, Please indicate the overall amount of disturbance or bother that you experience in your life as a result of your tinnitus. |
| Responder proportion at 4weeks post-intervention follow up | Week 13 | Responder proportion will be defined as number of participants with \>12- point change in Tinnitus Severity Short Form \[TSSF\] score at 4 weeks after the end of treatment compared to baseline divided by the total number of participants in each group. TSSF score ranges from 0 (mild) to 100 (severe) The responder proportion will be compared between the active and sham group. |
Countries
United States
Outcome results
None listed