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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cold pack-delivered mild therapeutic hypothermia
DeviceMild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.
Sham (No Treatment)
DeviceSham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Subjective Tinnitus Severity
An adapted 4-question visual analog scale (VAS) will be used to assess tinnitus awareness, loudness, tolerance and disturbance before baseline treatment and repeated immediately after application using the online survey module. The VAS has been adapted to address the current, acute subjective experience of the participants' tinnitus rather than their general experience. The VAS consists of a sliding scale from 0 to 100, with 100 correlating to a greater disease burden/worse symptoms.
Time frame
Immediately prior to and immediately after treatment or sham treatment.Secondary outcomes
1
Perceived Improvement of Tinnitus Symptoms
The Patient Global Impression of Improvement (PGI-I) scale will be administered immediately post-treatment using the online survey module. This scale will allow participants to rank, subjectively, how their tinnitus compares after treatment versus to before. The PGI-I is a written rather than numerical scale, with potential values ranging from "very much better" to "very much worse".
Time frame
Immediately after treatment or sham treatment.2
Comfort and Acceptability Questionnaire
A 6-item Device Acceptance Questionnaire (DAQ) will be used to assess the comfort and acceptability of the therapy (Aim 2). DAQ will be administered immediately after treatment in the experimental group. The DAQ consists of Likert scale questions pertaining to the comfort of the device, with responses including: "strongly disagree", "disagree", "agree", and "strongly agree".
Time frame
Immediately after treatment in the Experimental Arm.3
Adverse Events Questionnaire
A 2-question Adverse Event Questionnaire (AEQ) will be administered immediately post-treatment to record any mild adverse events associated with the therapy, including headache, dizziness, or irritation. Participants will identify adverse events they experienced from a provided list, with the option to add their own.
Time frame
Immediately after treatment or sham treatment.Sponsors and contacts
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Source ClinicalTrials.gov