Clinical trial NCT06782308: Tinnitus Patient Preferences Survey
Official title: Tinnitus Patient Preferences Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tinnitus, Subjective
Tinnitus, Bilateral
Tinnitus, Noise Induced
Tinnitus, Hearing Loss, Cochlear Implant Users
Keywords: tinnitus
iBCI
brain implant
survey
risks acceptance
user preferences
patient preferences
subjective tinnitus
chronic tinnitus
severe tinnitus
catastrophic tinnitus
invasive neuromodulation
surgical treatment
Lead sponsor: Neurosoft Bioelectronics SA
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (over 18 years old) with chronic, subjective severe tinnitus

Brief summary: The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). This survey covers the acceptance of a surgically-placed brain implant, of its associated risks related to the neurosurgical procedure, usability considerations, and the willingness/ability to pay for such a treatment.

Neurosoft Bioelectronics will use the collected patients' feedback and usability preferences data for the development of a novel minimally invasive brain implant aimed at alleviating tinnitus.

Detailed description: Neurosoft Bioelectronics is developing a minimally invasive implantable solution for the treatment of chronic, subjective moderate-to-severe cases of tinnitus. The approach involves developing a state-of-the-art neurostimulation paradigm and incorporating invasive neuromodulation findings from leading experts in the field to create an effective solution. This solution aims to minimize patient's burden by offering a fully implantable system that does not require active patient engagement or repetitive adjustments of electrical stimulation parameters. Instead, it will use a closed-loop feedback algorithm, that will be optimized through multi-target recordings and stimulation, to continuously adapt and refine the treatment. This type of solution could significantly increase the quality of life of affected individuals living with severe chronic tinnitus, for which only palliative and symptom management solutions exist today. As Neurosoft Bioelectronics is at the early stage of device development, we will use the collected patients' feedback and usability preferences data for refining clear users' and product's requirements.

Eligibility criteria: Inclusion criteria:

* Individuals aged 18 or older suffering from subjective tinnitus
* Self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus

Exclusion criteria:

* Individuals under 18 years of age
* Healthy volunteers without tinnitus

Primary outcomes:
measure: Acceptance of invasive neuromodulation treatments for chronic tinnitus
timeFrame: 1 year
Secondary outcomes:
measure: Usability preferences for implantable neuromodulation systems for chronic tinnitus
timeFrame: 1 year
measure: Willingness and ability to pay for novel invasive neuromodulation solutions for chronic tinnitus
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Neurosoft Bielectronics US Inc.
state: New York
Study officials:
affiliation: Neurosoft Bioelectronics
name: Nicolas Gninenko, PhD
role: PRINCIPAL_INVESTIGATOR
References: