None listed
Conditions
Brief summary
Tinnitus is a significant and growing health challenge globally, affecting individuals, their whanau, the wider community, and the healthcare system. Current treatments are ineffective and or are often associated with adverse effects. New innovative safer therapies are thus warranted. Our study will explore and test the effect of a novel approach pairing vagus nerve stimulation (VNS) and sound stimulation. The VNS has shown to activate the parasympathetic ‘rest-digest-restore’ response. If the sound stimulation is given immediately after the VNS (i.e., during the parasympathetic activation phase), it would potentially remove the salience attached to an otherwise meaningless tinnitus sound; thus resulting in improved clinical outcomes.
Interventions
Non-invasive vagus nerve stimulation (VNS) will be applied in conjunction with auditory stimulus. The intervention will be administered three times a week (30 minutes per session) for 3 weeks (9 sessions in total) using the DualSTIM multi-modal stimulator. The three sessions will not occur on three consecutive days; however, two days in a row will be allowed depending on the participants' schedules. Participants will fill out dated surveys when arriving for each session so session dates and atte
Non-invasive vagus nerve stimulation (VNS) will be applied in conjunction with auditory stimulus. The intervention will be administered three times a week (30 minutes per session) for 3 weeks (9 sessions in total) using the DualSTIM multi-modal stimulator. The three sessions will not occur on three consecutive days; however, two days in a row will be allowed depending on the participants' schedules. Participants will fill out dated surveys when arriving for each session so session dates and attendance will be recorded. The DualSTIM will electrically stimulate the auricular branch of the vagus nerve using small electrodes that clip to the tragus. It also features a headphone port for audio output. The auditory stimulus will be a tone generated to match a participant's tinnitus percept at each first session by a trained research assistant. Future sessions will also be managed by the same research assistant at a quiet room within Dunedin Hospital. Participants in the treatment groups will receive 1 second of VNS that is paired with 3 seconds of auditory stimulation (either simultaneously or with a 5 second delay). This will occur repeatedly every 15-20 seconds throughout each 30-minute treatment session. These 15-20 second stimulation periods will have random lengths.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of chronic, pure-tone tinnitus Tinnitus loudness of 4 or higher on a numeric rating scale Capable of understanding the study information and able to sign the informed consent form Age above 18 years on the day of the consent
Exclusion criteria
History of neurological diseases History of epilepsy or seizures Current substance use disorders Cognitive impairments (dementia, Alzheimer’s disease, personality disorders, substance use disorders, certain medical conditions): a total score of 24 or below on Mini-Mental State Examination Presence of any pacemaker or defibrillator Presence of any electronic implants or metal implant in the body (particularly head and neck)
Outcome results
None listed