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Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

Primary Purpose

Tinnitus

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lenire bimodal stimulation device

About this trial

This is an interventional device feasibility trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years and over at time of consent
Ability to read and understand English
Willing and able to provide and understand informed consent
Willing to commit to the full duration of the investigation
Subjective tinnitus
Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
Baseline THI score from 38 to 76
Hearing loss condition (low hearing loss group (n=10) and high hearing loss group (n=10))
Access to reliable internet connection and device to complete virtual video visits and electronic surveys

Exclusion Criteria:

Subjective tinnitus, where pulsatility is the dominant feature
Objective tinnitus
Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed
Began wearing hearing aids within the past 3 months
Health care provider has rendered a diagnosis of Meniere's disease or other disorder with fluctuating hearing loss
A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered
History of auditory hallucinations
Tumor on the hearing or balance nervous systems
Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
Participant with a pacemaker or other electro-active implanted device
Participant previously diagnosed with psychosis or schizophrenia
Participants diagnosed with Burning Mouth Syndrome
A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
Inability to physically or comprehensively use the device
Oral piercings that cannot or will not be removed
Current or previous involvement in medico-legal cases
Pregnancy per patient report
Prisoner
PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.

Sites / Locations

University of Minnesota - TESSLab/PWB

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single study arm

Arm Description

The Lenire device is CE marked in Europe and intended to reduce the symptoms of tinnitus. It comprises a handheld controller and an intra-oral device called a Tonguetip® Intra-Oral Device (IOD), which delivers gentle electrical stimulation to the tongue, and also comprises of a set of wireless consumer headphones that deliver audio stimulation. The sound and tongue stimulus parameters such as stimulus rate, stimulus intensity, and the timing relationship between the auditory and somatosensory stimulus events are grouped into stimulation Parameter Sets (PS). PS1 is used during the first 6-weeks of stimulation and PS4 is used during the second 6-weeks of stimulation, similar to what is routinely used for tinnitus individuals in Europe. For this study, the device software has been modified to allow users to adjust the headphone volume to a level that is comfortable and clearly audible instead of a preset volume with limited adjustments based on the patient's audiogram.

Outcomes

Primary Outcome Measures

Compliance rate after 12 weeks of bimodal stimulation

Compliance rate after 12 weeks of bimodal stimulation with minimum compliance of a total of 36 hours

Secondary Outcome Measures

Satisfaction rate after 12 weeks of bimodal stimulation

Satisfaction rate (two satisfaction questions) after 12 weeks of bimodal stimulation

Full Information

NCT ID

NCT05518682

First Posted

August 24, 2022

Last Updated

September 13, 2023

Sponsor

University of Minnesota

Collaborators

Neuromod Devices Limited, Kent Taylor

1. Study Identification

Unique Protocol Identification Number

NCT05518682

Brief Title

Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

Official Title

Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 19, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

Neuromod Devices Limited, Kent Taylor

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the ability to self-adjust the sound stimulus presented to the ears via headphones. In particular, the CE marked bimodal stimulation portable device, Lenire, which is developed by Neuromod Devices Limited (Dublin, Ireland) to alleviate the symptoms of chronic subjective tinnitus, is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during fitting in a hearing center. Lenire device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 10 weeks. Lenire is already commercialized across Europe and available by audiologists or hearing technicians in numerous hearing centers for treating tinnitus. It has also been evaluated in two large-scale clinical trials in over 500 tinnitus participants, demonstrating tinnitus benefit and minimal risk with high compliance and satisfaction rates. The primary objective of the proposed usability study is to first assess compliance and satisfaction with the Lenire device that does not require an audiogram for fitting and that can be implemented mostly through virtual visits (except for the first visit). These modifications to the Lenire fitting process will reduce the time and personnel effort required for its implementation, enabling a broader patient population to access bimodal stimulation for tinnitus treatment, including military personnel and those who are not nearby hearing centers for in-person sessions. High compliance and satisfaction rates from this small proof-of concept usability study will then justify and guide a larger clinical study to assess efficacy and performance of this newly implemented Lenire device process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

One arm with the same device protocol, except that there are two subgroups with different hearing/audiogram profiles.

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single study arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Lenire bimodal stimulation device

Other Intervention Name(s)

PS1-PS4

Intervention Description

The sound and tongue stimulus parameters such as stimulus rate, stimulus intensity, and the timing relationship between the auditory and somatosensory stimulus events are grouped into stimulation Parameter Sets (PS). PS1 is used during the first 6-weeks of stimulation and PS4 is used during the second 6-weeks of stimulation, similar to what is routinely used for tinnitus individuals in Europe.

Primary Outcome Measure Information:

Title

Compliance rate after 12 weeks of bimodal stimulation

Description

Compliance rate after 12 weeks of bimodal stimulation with minimum compliance of a total of 36 hours

Time Frame

Enrollment visit to week 12 visit (end of device stimulation)

Secondary Outcome Measure Information:

Title

Satisfaction rate after 12 weeks of bimodal stimulation

Description

Satisfaction rate (two satisfaction questions) after 12 weeks of bimodal stimulation

Time Frame

Enrollment visit to week 12 visit (end of device stimulation)

Other Pre-specified Outcome Measures:

Title

Impact of the stimulation device on tinnitus symptoms after 12 weeks of bimodal stimulation

Description

Tinnitus Handicap Inventory (THI)

Time Frame

Enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit

Title

Impact of the stimulation device on tinnitus symptoms after 12 weeks of bimodal stimulation

Description

Tinnitus Functional Index (TFI)

Time Frame

Enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit

Title

Impact of the stimulation device on tinnitus symptoms after 12 weeks of bimodal stimulation

Description

Visual Analog Scale for Loudness (VAS-L)

Time Frame

Enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit

Title

Impact of the stimulation device on health after 12 weeks of bimodal stimulation

Description

Patient Health Questionnaire (PHQ-8)

Time Frame

Enrollment visit to week 12 visit (end of device stimulation)

Title

Impact of the stimulation device on stress after 12 weeks of bimodal stimulation

Description

Perceived Stress Scale (PSS-10)

Time Frame

Enrollment visit to week 12 visit (end of device stimulation)

Title

Impact of the stimulation device on anxiety after 12 weeks of bimodal stimulation

Description

Generalized Anxiety Disorder (GAD-7)

Time Frame

Enrollment visit to week 12 visit (end of device stimulation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years and over at time of consent Ability to read and understand English Willing and able to provide and understand informed consent Willing to commit to the full duration of the investigation Subjective tinnitus Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent Baseline THI score from 38 to 76 Hearing loss condition (low hearing loss group (n=10) and high hearing loss group (n=10)) Access to reliable internet connection and device to complete virtual video visits and electronic surveys Exclusion Criteria: Subjective tinnitus, where pulsatility is the dominant feature Objective tinnitus Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed Began wearing hearing aids within the past 3 months Health care provider has rendered a diagnosis of Meniere's disease or other disorder with fluctuating hearing loss A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered History of auditory hallucinations Tumor on the hearing or balance nervous systems Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments. Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments. Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments. Any use of benzodiazepines or sedative hypnotics (either regularly or on demand) Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy) Participant with a pacemaker or other electro-active implanted device Participant previously diagnosed with psychosis or schizophrenia Participants diagnosed with Burning Mouth Syndrome A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus Inability to physically or comprehensively use the device Oral piercings that cannot or will not be removed Current or previous involvement in medico-legal cases Pregnancy per patient report Prisoner PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meredith Adams, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peggy Nelson, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota - TESSLab/PWB

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

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Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

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