Noninvasive Therapy for Tinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRestorear Devices LLC
About this trial
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims:
1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older at the time of signing the consent form
Fluency in English or Spanish
Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours
At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI)
Disqualifiers
Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7)
Tinnitus described as non-auditory or pulsatile in nature
Catastrophic tinnitus, score ≥78 on the THI
Tinnitus that is intermittent in nature
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 device
DeviceSham headband-style device. Participants assigned to use this device will be told they are receiving therapy for 30 minutes. However, no therapy is being provided.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Mild Therapeutic Hypothermia (MTH) ArmExperimental treatment 1 intervention
Group B: Control ArmSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS) of Tinnitus Severity
3-item instrument used to assess participant's subjective perception of tinnitus. Includes sliding scales used by participants to score their perceived disease severity. VAS will be used to assess perceived tinnitus severity before baseline treatment and repeated immediately after treatment. The VAS consists of a sliding scale from 0 to 10, with 10 correlating to a greater disease burden/worse symptoms.
Time frame
VAS will be given to participants in both Experimental and Sham Arms. For Aim 1, VAS will be administered at baseline, immediately after treatment, and at 24 hours post-treatment. For Aim 2, VAS will be administered monthly for 6 months post-baseline.2
Tinnitus Functional Index Adapted (TFI-Adapted)
25-item instrument with eight subscales; (1) Intrusiveness, (2) Sense of control, (3) Cognition, (4) Sleep, (5) Auditory, (6) Relaxation, (7) Quality of life, and (8) Emotional distress. Each subscale can be scored separately, allowing for relevant items to be summed and weighted for analysis. TFI questions will be adapted to ask participants about their tinnitus experience over the past 24 hours.
Time frame
TFI-Adapted will be given to participants in Aim 1. TFI-Adapted will be administered at baseline and 24 hours post-treatment.Secondary outcomes
1
Pure Tone Audiometry
PTA will be measured in Aim 1 for frequencies 250 - 8,000 Hz and high frequencies of \> 8,000 Hz.
Time frame
PTA will be measured in Aim 1 at baseline and immediately after treatment.2
Distortion Product Otoacoustic Emissions (DPOAE)
DPOAE will be measured in Aim 1 for 1,500 - 10,000 Hz. DPOAEs will be recorded and analyzed using f2 tone frequencies with a fixed primary ratio (f2/f1) of 1.22, L1 = 65 dB SPL, L2 = 55 dB SPL.
Time frame
DPOAE will be measured in Aim 1 at baseline and immediately after treatment.3
Auditory Brainstem Response (ABR)
Test measuring the brain's electrical activity in response to sound to assess hearing and neurological function. ABR will be recorded using 77 dB nHL. At least 2 averaged responses will be performed to ensure replicability.
Time frame
ABR will be measured in Aim 1 at baseline and immediately after treatment.4
Tinnitus Pitch & Loudness Matching
Psychoacoustic measurements of each participant's tinnitus will be performed to qualify tinnitus pitch.
Time frame
Tinnitus pitch and loudness matching will be measured in Aim 1 at baseline and immediately after treatment.Other outcomes
1
Tinnitus Handicap Inventory (THI)
25-item instrument used to assess the handicap experienced by the participant due to tinnitus. THI assesses functional, emotional, and catastrophic response reactions to tinnitus on a 4-point scale totaling 100, with degree of handicap increasing with score.
Time frame
The THI will be administered as part of enrollment determination and at 6 months post-baseline.2
Tinnitus Therapy Use
2-question survey to collect data on the number of times the ReBound device was worn in the past month.
Time frame
This instrument will be administered monthly for 6 months post-baseline.3
Adverse Event Questionnaire (AEQ)
2-question survey to collect data on any adverse event associated with use of the device.
Time frame
AEQ will be administered immediately after treatment, 24 hours post-treatment, and monthly for 6 months post-baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Restorear Devices LLC
Lead sponsor
University of Miami
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov