Actively Recruiting
External Therapy for Tinnitus Management
Led by Restorear Devices LLC · Updated on 2025-09-17
80
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are: 1. Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change. 2. Ascertain the comfort and acceptability of the hypothermia device and therapy. Participants with chronic tinnitus will wear the mild therapeutic hypothermia therapy devices for a single 30 minute session. Researchers will compare results from those receiving therapy to those from a control group.
CONDITIONS
Official Title
External Therapy for Tinnitus Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years at the time of consent with primary complaint of tinnitus
- Subjective tinnitus lasting at least 30 days
- Tinnitus severity with Tinnitus Handicap Inventory (THI) score of 12 or higher
- Constant tinnitus audible at least 75% of waking hours
You will not qualify if you...
- Very mild tinnitus with THI score less than 12
- Intermittent tinnitus
- Tinnitus described as non-auditory or pulsatile
- History of vertigo or fluctuating hearing loss related to conditions like Meni�e8re's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder
- History of extreme sensitivity to cold or heat, including frostbite or Raynaud's Syndrome
- Currently receiving medical, pharmacologic, or therapeutic treatment for tinnitus or other ear conditions, including sound therapy, CBT, TRT, steroid injections, or others
- Significant psychological issues indicated by moderate to severe anxiety or depression based on PHQ-4 score
- Children under 18 years, incarcerated individuals, adults unable to consent, or psychologically vulnerable participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
RestorEar Devices
Bozeman, Montana, United States, 59715
Actively Recruiting
Research Team
K
Kendall Stern, MPH
CONTACT
S
Suhrud Rajguru, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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