Bimodal Stimulation Using Auditory and Vibrotactile Stimuli for the Mitigation of Tinnitus

NCT06508060 | Not Yet Recruiting FDA Device

• 1 other identifier: 2016/01/7
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist works to treat moderate to severe tinnitus in adults. It will also learn about the safety of the device. The main questions it aims to answer are:

1. 1.Does a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist decrease the severity of tinnitus symptoms in adults with moderate to severe tinnitus?
2. 2.What medical problems do participants report when using a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist?
3. 3.Use the bimodal stimulation device for 10 minutes every day for a period of 8 weeks
4. 4.Have one-on-one calls with the research team at the beginning and end of the study
5. 5.Complete baseline and final tinnitus functional index assessments to track progress as a result of the intervention.

Conditions

Tinnitus

Keywords

Biomodal stimulation; Tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index

  The Tinnitus Functional Index (TFI) is a self-report questionnaire that measures the severity and negative effects of tinnitus. It's used to assess how tinnitus affects a person in multiple domains, and can also be used to measure changes in tinnitus related to treatment.

  From the first day of treatment to the final day of treatment at 8 weeks

Study Arms (2)

Tones combined with vibrotactile stimulation

EXPERIMENTAL

The experimental group will receive treatment consisting of tones combined with vibrotactile stimulation delivered from a haptic wristband.

Device: Neosensory Wristband

Tones alone

OTHER

The control group will receive treatment consisting of tones alone, without the addition of vibrotactile stimulation from a wristband.

Other: Tones only

Interventions

Neosensory Wristband DEVICE

The Neosensory wristband consists of four vibratory motors built into the strap of the wristband (Figure 1a). The motors are linear resonant actuators (LRAs), vibrating at 175 Hz, capable of rising from 0 to 50% of their intensity within 30 ms. The motor intensity can be controlled with an eight bit resolution, meaning each motor can be controlled at 256 different intensities. At the highest intensity, each motor vibrates at 1.7 GRMS. The motors are separated from one another at a distance of 18.2 mm and 19.2 mm for the small and large wristband sizes, respectively (center-to-center distances). The top of the wristband is a module that contains the power button, user setting buttons, a microphone, and a microcontroller. Bluetooth communication is used to create the corresponding vibrations on the wristband. While the study app plays the tones, it also sends a Bluetooth command to the wristband such that the wristband vibrates in the appropriate illusory location.

Tones combined with vibrotactile stimulation

Tones only OTHER

Tones will be played through an app

Tones alone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide and understand informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Initial Tinnitus Functional Index Score of 42 points or higher indicating mild, moderate, or severe tinnitus
• Subjective tinnitus that is described as tonal or white noise
• Age 22 and over at the time of consent
• Ability to read and understand English
• Tinnitus duration for greater than or equal to 3 months
• Able to provide an audiogram performed by a licensed audiologist within the past 12 months

You may not qualify if:

• Individuals who are non-English speaking
• Subjective tinnitus, where pulsatility is the dominant feature (participant reported)
• Objective tinnitus, where the tinnitus is also observed by the examiner
• Commenced usage of hearing aid within the last 90 days
• Meniere\'s disease
• Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
• TMJ Disorder
• Pregnancy
• Neurological condition that may lead to seizures or loss of consciousness (e.g. epilepsy)
• Severe cognitive impairment based on MMSE (score less than 20)
• Abnormal findings following otoscopy/tympanometry that may be contributing to or causing the tinnitus as assessed by an Audiologist/ENT (participant reported)
• Initiated new prescription medications or medical treatments in the previous 3 months
• Ceased prescription medications or medical treatments in the previous 3 months
• Participant previously diagnosed with psychosis or schizophrenia
• Previous use of Neosensory Duo

Sponsors & Collaborators

• Neosensory: lead

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Izzy Kohler, DPT

CONTACT

585-943-0580; kohler@neosensory.com

David Eagleman, PhD

CONTACT

650-385-8440; eagleman@neosensory.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share