External Therapy for Tinnitus Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRestorear Devices LLC
About this trial
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.
Eligibility criteria
Qualifiers
Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus;
Suffering from subjective tinnitus for at least 30 days;
Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12,
Tinnitus is constant in nature (defined as audible at least 75% of waking hours).
Disqualifiers
Very mild tinnitus (THI values <12);
Tinnitus that is intermittent in nature;
Tinnitus described as non-auditory or pulsatile in nature;
Individuals with a history of vertigo or fluctuating hearing loss, such as that related to Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder;
Trial design
Treatments tested in this trial
- Cold pack-delivered mild therapeutic hypothermia
- Sham (No Treatment)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov