Health Condition 1: H838- Other specified diseases of innerear
Conditions
Interventions
Intervention1: Transcutaneous vagus nerve stimulation with sound therapy and tinnitus educational counselling: Participants will receive transcutaneous vagus nerve stimulation delivered using a non in
Sponsors
Sagrika Sharma
Eligibility
Inclusion criteria
Inclusion criteria: subjects within age range of 18-55 years with subjective (can be heard only by oneself) and chronic (greater than 3 months) tinnitus which is continuous in both or one ear. These subjects can be with or without hearing loss, but hearing loss not exceeding more than 50 dBHL in all frequencies i.e. 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz and 8000 Hz.
Exclusion criteria
Exclusion criteria: subjects with intermittent (not continuous throughout) or pulsatile tinnitus (vascular in origin) or can be heard by others (objective tinnitus). Subjects having any other otological disorder like Meniere s disease or otosclerosis, neuropsychiatric, respiratory, or cardiac issues. Subjects with implanted device such as pacemaker or any neurostimulation device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus-related distress measured using Tinnitus Functional IndexTimepoint: Baseline 1-month follow-up 3-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Tinnitus severity measured using Tinnitus Handicap InventoryTimepoint: Baseline 1-month follow-up 3-month follow-up;Perceived tinnitus loudness measured using visual analogue scaleTimepoint: Baseline 1-month follow-up 3-month follow-up;Sleep quality and stress using validated questionnaireTimepoint: Baseline 1-month follow-up 3-month follow-up;Electrophysiological tests like P300 and MMNTimepoint: Baseline 1-month follow-up 3-month follow-up | — |
Countries
India
Contacts
Public ContactSanjay Kumar Munjal
PGIMER
Outcome results
None listed