Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT07158034
Eligibility Criteria:
Treatment Group 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 (only for participants in treatment group)
* Baseline THI score from 40 to 76 (only for participants in treatment group)
* Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)
Treatment Group Exclusion Criteria:
* Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group)
* Objective tinnitus
* Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting
* Began wearing hearing aids within the past 3 months
* A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss.
* 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.
* 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.
* 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.
* 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
* 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.
Control Group 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
Control Group Exclusion Criteria:
* Began wearing hearing aids within the past 3 months
* 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.
* 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.
* 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.
* 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 previously diagnosed with psychosis or schizophrenia
* A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
* Prisoner
* PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07158034
Study Brief:
Protocol Section:
NCT07158034