Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard University | OTHER |
Not provided
Not provided
Not provided
Not provided
The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).
The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory Mirror Therapy Device | Experimental | Modified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa. |
|
| Sham Headphone Device | Sham Comparator | Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory Mirror Therapy | Device | 21 days, up to 3 hours per day intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tinnitus Functional Index (TFI) | The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress. The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tinnitus Handicap Inventory (THI) | a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living. | 3 weeks |
| Change in Visual Analogue Scale (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Mirror Therapy Questionnaire | developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here | 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35079989 | Result | Linnman C. Auditory Mirror Therapy for Tinnitus: A Pilot Study. J Am Acad Audiol. 2022 Apr;33(4):220-223. doi: 10.1055/a-1749-9279. Epub 2022 Dec 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active AMT Device | active auditory mirror therapy device |
| FG001 | Sham | sham AMT device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with tinnitus
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active AMT Device | active auditory mirror therapy device |
| BG001 | Sham | sham AMT device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Tinnitus Functional Index (TFI) | The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress. The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity. | completed study with TFI data | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
9 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auditory Mirror Therapy Device | Modified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa. Auditory Mirror Therapy: 21 days, up to 3 hours per day intervention |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Clas Linnman | Spaulding Rehabilitation Hopsital | 8572842816 | clinnman@mgb.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | Jan 20, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2022 | Jan 20, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Concealment of treatment allocation is not possible
Not provided
Scale from 0 to 100 for tinnitus awareness, loudness and annoyance, on separate VAS.
VAS loudness and annoyance are valid and effective measurements for capturing reductions in tinnitus severity in patients with chronic tinnitus
| 3 weeks |
| Change in Minimum Masking Level (MML) and Residual Inhibition (RI) | MML is defined as the lowest tone intensity level required to cover or mask and individual's tinnitus. Correspondingly, the RI is considered the temporary decrease of tinnitus after a prolonged acoustic stimulation. | 3 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tinnitus functional index | The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Sham Headphone Device |
Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector Auditory Mirror Therapy: 21 days, up to 3 hours per day intervention |
|
|
|
| Secondary | Change in Tinnitus Handicap Inventory (THI) | a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living. | Not Posted | 3 weeks | Participants |
| Secondary | Change in Visual Analogue Scale (VAS) | Scale from 0 to 100 for tinnitus awareness, loudness and annoyance, on separate VAS. VAS loudness and annoyance are valid and effective measurements for capturing reductions in tinnitus severity in patients with chronic tinnitus | Not Posted | 3 weeks | Participants |
| Secondary | Change in Minimum Masking Level (MML) and Residual Inhibition (RI) | MML is defined as the lowest tone intensity level required to cover or mask and individual's tinnitus. Correspondingly, the RI is considered the temporary decrease of tinnitus after a prolonged acoustic stimulation. | Not Posted | 3 weeks | Participants |
| Other Pre-specified | Auditory Mirror Therapy Questionnaire | developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here | Not Posted | 3 weeks | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Sham Headphone Device | Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector Auditory Mirror Therapy: 21 days, up to 3 hours per day intervention | 0 | 23 | 0 | 23 | 0 | 23 |
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |