External Therapy for Tinnitus Management

NCT07017998 | Recruiting DMC FDA Device

• 1 other identifier: IRB-FY2025-39
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change.
2. 2.Ascertain the comfort and acceptability of the hypothermia device and therapy.

Conditions

Tinnitus; Tinnitus, Subjective

Keywords

tinnitus; ringing in the ears; ringing ears; symptom management; cooling; red light therapy

Outcome Measures

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.

  Immediately prior to and immediately after treatment or sham treatment.

Secondary Outcomes (3)

• Perceived Improvement of Tinnitus Symptoms

  Immediately after treatment or sham treatment.

• Comfort and Acceptability Questionnaire

  Immediately after treatment in the Experimental Arm.

• Adverse Events Questionnaire

  Immediately after treatment or sham treatment.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Participants will wear a headband-style device for 30 minutes in a single session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Sham Arm. n=40

Device: Cold pack-delivered mild therapeutic hypothermia

Control Arm

SHAM COMPARATOR

Participants will wear a headband-style control device for a single 30 minute session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Experimental Arm. n=40

Device: Sham (No Treatment)

Interventions

Cold pack-delivered mild therapeutic hypothermia DEVICE

Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.

Experimental Arm

Sham (No Treatment) DEVICE

Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.

Control Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome.
• Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions, including sound therapy, cognitive behavioral therapy (CBT), Tinnitus Retraining Therapy (TRT), steroid injections, or other treatments;
• Those who present with a mental health score indicating significant psychological component, per standard of care, based on PHQ-4 score of moderate to severe anxiety/depression.
• Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.

Sponsors & Collaborators

• Restorear Devices LLC: lead

Study Sites (1)

RestorEar Devices

Bozeman, Montana, 59715, United States

RECRUITING

Related Publications (16)

• Saatci, O., O.A. Duz, and N.G.Y. Aslier, Efficacy of caloric vestibular stimulation for the treatment of idiopathic tinnitus. Journal of Surgery and Medicine, 2020. 4(11): p. 1041-1045.

  BACKGROUND

• Lamprecht J, Morgenstern C. [Bilateral caloric long-term irrigation as a method for the differentiation of tonal tinnitus]. Laryngol Rhinol Otol (Stuttg). 1985 Jan;64(1):17-20. German.

  PMID: 3968937 BACKGROUND

• Rincon Sabatino S, Rivero A, Sangaletti R, Dietrich WD, Hoffer ME, King CS, Rajguru SM. Targeted therapeutic hypothermia protects against noise induced hearing loss. Front Neurosci. 2024 Jan 16;17:1296458. doi: 10.3389/fnins.2023.1296458. eCollection 2023.

  PMID: 38292902 BACKGROUND

• Rincon Sabatino S, Sangaletti R, Griswold A, Dietrich WD, King CS, Rajguru SM. Transcriptional response to mild therapeutic hypothermia in noise-induced cochlear injury. Front Neurosci. 2024 Jan 17;17:1296475. doi: 10.3389/fnins.2023.1296475. eCollection 2023.

  PMID: 38298897 BACKGROUND

• Tamames I, King C, Huang CY, Telischi FF, Hoffer ME, Rajguru SM. Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. Ear Hear. 2018 Jul/Aug;39(4):712-719. doi: 10.1097/AUD.0000000000000529.

  PMID: 29240567 BACKGROUND

• Tamames I, King C, Bas E, Dietrich WD, Telischi F, Rajguru SM. A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. Hear Res. 2016 Sep;339:32-9. doi: 10.1016/j.heares.2016.05.015. Epub 2016 May 31.

  PMID: 27260269 BACKGROUND

• Henry KR. Hyperthermia exacerbates and hypothermia protects from noise-induced threshold elevation of the cochlear nerve envelope response in the C57BL/6J mouse. Hear Res. 2003 May;179(1-2):88-96. doi: 10.1016/s0378-5955(03)00097-2.

  PMID: 12742241 BACKGROUND

• Watanabe F, Koga K, Hakuba N, Gyo K. Hypothermia prevents hearing loss and progressive hair cell loss after transient cochlear ischemia in gerbils. Neuroscience. 2001;102(3):639-45. doi: 10.1016/s0306-4522(00)00510-8.

  PMID: 11226700 BACKGROUND

• Henry KR, Chole RA. Hypothermia protects the cochlea from noise damage. Hear Res. 1984 Dec;16(3):225-30. doi: 10.1016/0378-5955(84)90111-4.

  PMID: 6401081 BACKGROUND

• Meisel-Mikolajczyk F, Swoboda-Kopec E, Skoskiewicz M. [Isolation of Bacteroides fragilis from the appendix in a case of appendicitis]. Pol Tyg Lek. 1977 Aug 1;32(31):1209-10. No abstract available. Polish.

  PMID: 896576 BACKGROUND

• Liberman MC, Dodds LW. Single-neuron labeling and chronic cochlear pathology. II. Stereocilia damage and alterations of spontaneous discharge rates. Hear Res. 1984 Oct;16(1):43-53. doi: 10.1016/0378-5955(84)90024-8.

  PMID: 6511672 BACKGROUND

• Brown MC, Smith DI, Nuttall AL. The temperature dependency of neural and hair cell responses evoked by high frequencies. J Acoust Soc Am. 1983 May;73(5):1662-70. doi: 10.1121/1.389387.

  PMID: 6863743 BACKGROUND

• Eggermont JJ, Roberts LE. The neuroscience of tinnitus: understanding abnormal and normal auditory perception. Front Syst Neurosci. 2012 Jul 11;6:53. doi: 10.3389/fnsys.2012.00053. eCollection 2012. No abstract available.

  PMID: 22798948 BACKGROUND

• Sheldrake J, Diehl PU, Schaette R. Audiometric characteristics of hyperacusis patients. Front Neurol. 2015 May 15;6:105. doi: 10.3389/fneur.2015.00105. eCollection 2015.

  PMID: 26029161 BACKGROUND

• Sanchez TG, Medeiros IR, Levy CP, Ramalho Jda R, Bento RF. Tinnitus in normally hearing patients: clinical aspects and repercussions. Braz J Otorhinolaryngol. 2005 Jul-Aug;71(4):427-31. doi: 10.1016/s1808-8694(15)31194-0. Epub 2005 Dec 15.

  PMID: 16446955 BACKGROUND

• Baguley D, McFerran D, Hall D. Tinnitus. Lancet. 2013 Nov 9;382(9904):1600-7. doi: 10.1016/S0140-6736(13)60142-7. Epub 2013 Jul 2.

  PMID: 23827090 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suhrud Rajguru, PhD

  RestorEar Devices

  PRINCIPAL INVESTIGATOR

• Kendall Stern, MPH

  RestorEar Devices

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendall Stern, MPH

CONTACT

(406) 414-6278; kendall.stern@restorear.com

Suhrud Rajguru, PhD

CONTACT

(801) 641-8180; srajguru@restorear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, single-blind and decentralized randomized control study. All study procedures and data collection will be completed by participants remotely using online modules under the guidance of an audiologist. Participants will be sent a test kit to complete the study procedures on their own time and will access an online module for data collection via Qualtrics XM. Participants will be asked to use a wearable, headband-style device and to respond to questions about their tinnitus experience.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)