Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus

NCT06083519 | Recruiting

• 1 other identifier: TinnitusProject_2023-333
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effectiveness of a sound-based passive treatment for reducing stress and annoyance induced by tinnitus, and how this therapy may improve tinnitus sufferers' quality of life. The main questions it aims to answer are: • \[question 1: to assess the efficacy of the LUCID/VIBE in managing the tinnitus handicap (measured by the reducing of the annoyance/stress response to tinnitus) contributing to the improvement of the quality of life of people living with tinnitus\] and • \[question 2: assess the efficacy of LUCID/VIBE in providing temporary relief through masking, such that it results in a reduction of the perceived loudness of tinnitus\]. Participants will \[use the VIBE app for 24 minutes a day for a period of 4 weeks. There will be two conditions, a Noise condition (the control condition in which the investigator will administer white noise) and the VIBE condition (the treatment condition). One approach involves broad-band masking with noise (Noise Condition), while the other uses music (LUCID Condition). Implementation of the noise condition will mirror the LUCID condition in terms of ease of access, look, feel, so that one condition does not look less professional than the other. Both conditions will be administered through the same app, and only the sound conditions will differ (white noise vs. LUCID music). All participants will be exposed to both the treatment and control conditions with the order of conditions counter-balanced (i.e., a cross-over design).

Conditions

Tinnitus

Keywords

tinnitus; iso principle; artificial intelligence; auditory perception; sound therapy; neuroscience; neuromodulatory intervention; auditory beat stimulation

Outcome Measures

Primary Outcomes (2)

• Tinnitus Functional Index

  The Tinnitus Functional Index is a self-report questionnaire. It is measuring the negative impact and severity of tinnitus, as well as to provide sensitive measurements to change based on treatment administration (i.e., responsiveness). This questionnaire consists of 25 questions administered in a Likert-Scale fashion ranging of a maximum value of 10 and a minimum value of 0 per question. In total, the maximum value a participant can score is 250 and the minimum is 0. A higher score (i.e., a score closer to 250), represents experiencing tinnitus at greater severity and experiencing a more negative impact from it.

  The questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. The measurements will be compared to see if the intervention created a change.

• 36-item Short Form Health Survey

  The 36-item Short Form Health Survey is a measurement tool used to assess subjective quality of life. A study has found this tool to be reliable and valid.

  The questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. The measurements will be compared to see if the intervention created a change.

Secondary Outcomes (1)

• Visual Analogue System

  Up to 48 hours after each usage.

Study Arms (2)

White Noise

SHAM COMPARATOR

Participants listened to white noise for 24 minutes

Behavioral: White Noise

LUCID Music

EXPERIMENTAL

Participants listened to music chosen from the VIBE app with theta auditory beat stimulation for 24 minutes

Behavioral: Music and Auditory Beat Stimulation

Interventions

White Noise BEHAVIORAL

This is the control condition. Listening to white noise -- participants listen to white noise for 24 minutes

White Noise

Music and Auditory Beat Stimulation BEHAVIORAL

Listening to music and auditory beat stimulation. The VIBE app (LUCID) incorporates theta-band (4 Hz) auditory beat stimulation and an auditory music recommendation system. Participants will listen to this music with theta auditory beat stimulation for 24 minutes.

Also known as: LUCID Music

LUCID Music

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pure-Tone Average hearing loss (500, 1000, 2000, 4000) of 30 decibels hearing loss or greater in the better ear.
• Tinnitus Handicap Index scores of 18 to 76 (mild to severe handicap).
• Self-report of chronic, non-intermittent tinnitus experienced \> 3 months

You may not qualify if:

• Adults younger than 40 years old, or adults older than 85 years old.
• Pulsatile tinnitus (tinnitus that modulates synchronously with a participant's pulse)
• \>20 dB HL difference in pure-tone average between ears
• \> 80 dB HL PTA averaged across ears
• Individuals currently undergoing other tinnitus treatment programs will not be able to participate in our study. This is to ensure that our findings are accurately attributed to our App and not influenced by external factors. If someone is already receiving treatment for their tinnitus, it would be challenging to distinguish the effects of our App from their existing treatment regimen. To eliminate the possibility of such confounding factors, our team kindly asks participants to disclose if they are undergoing other treatments for tinnitus.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Lucid, Inc.: collaborator
• Sonova Canada Inc.: collaborator
• Mitacs: collaborator

Study Sites (1)

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

RECRUITING

Related Publications (16)

• Aazh H, Salvi R. The Relationship between Severity of Hearing Loss and Subjective Tinnitus Loudness among Patients Seen in a Specialist Tinnitus and Hyperacusis Therapy Clinic in UK. J Am Acad Audiol. 2019 Sep;30(8):712-719. doi: 10.3766/jaaa.17144. Epub 2018 Nov 8.

  PMID: 30403955 BACKGROUND

• Garcia-Argibay M, Santed MA, Reales JM. Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis. Psychol Res. 2019 Mar;83(2):357-372. doi: 10.1007/s00426-018-1066-8. Epub 2018 Aug 2.

  PMID: 30073406 BACKGROUND

• Gopinath B, McMahon CM, Rochtchina E, Karpa MJ, Mitchell P. Risk factors and impacts of incident tinnitus in older adults. Ann Epidemiol. 2010 Feb;20(2):129-35. doi: 10.1016/j.annepidem.2009.09.002.

  PMID: 20123163 BACKGROUND

• Hall DA, Haider H, Szczepek AJ, Lau P, Rabau S, Jones-Diette J, Londero A, Edvall NK, Cederroth CR, Mielczarek M, Fuller T, Batuecas-Caletrio A, Brueggemen P, Thompson DM, Norena A, Cima RF, Mehta RL, Mazurek B. Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults. Trials. 2016 Jun 1;17(1):270. doi: 10.1186/s13063-016-1399-9.

  PMID: 27250987 BACKGROUND

• Hullfish J, Sedley W, Vanneste S. Prediction and perception: Insights for (and from) tinnitus. Neurosci Biobehav Rev. 2019 Jul;102:1-12. doi: 10.1016/j.neubiorev.2019.04.008. Epub 2019 Apr 15.

  PMID: 30998951 BACKGROUND

• Mallik A, Russo FA. The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial. PLoS One. 2022 Mar 9;17(3):e0259312. doi: 10.1371/journal.pone.0259312. eCollection 2022.

  PMID: 35263341 BACKGROUND

• McConnell PA, Froeliger B, Garland EL, Ives JC, Sforzo GA. Auditory driving of the autonomic nervous system: Listening to theta-frequency binaural beats post-exercise increases parasympathetic activation and sympathetic withdrawal. Front Psychol. 2014 Nov 14;5:1248. doi: 10.3389/fpsyg.2014.01248. eCollection 2014.

  PMID: 25452734 BACKGROUND

• Nondahl DM, Cruickshanks KJ, Dalton DS, Klein BE, Klein R, Schubert CR, Tweed TS, Wiley TL. The impact of tinnitus on quality of life in older adults. J Am Acad Audiol. 2007 Mar;18(3):257-66. doi: 10.3766/jaaa.18.3.7.

  PMID: 17479618 BACKGROUND

• Zhang Y, Qu B, Lun SS, Guo Y, Liu J. The 36-item short form health survey: reliability and validity in Chinese medical students. Int J Med Sci. 2012;9(7):521-6. doi: 10.7150/ijms.4503. Epub 2012 Aug 27.

  PMID: 22991490 BACKGROUND

• Rider, M. S. (1985). Entrainment mechanisms are involved in pain reduction, muscle relaxation, and musicmediated imagery. Journal of Music Therapy, 22(4), 183-92. doi: 10.1093/jmt/22.4.183.

  BACKGROUND

• Heiderscheit, A., Madson, A. (2015). Use of the iso principle as a central method in mood management: A music psychotherapy clinical case study. Music Therapy Perspectives, 33(1), 45-52.

  BACKGROUND

• Labbé A, McMahon, Z., & Thomson, Z. (2021). Music as Medicine: LUCID Science + Technology White Paper. [White Paper]. Available online at https://uploads ssl.webflow.com/60b8a3f8bd91d547f8a453dc/614e1cead49a3cadb1880924_Whitepaper%20- %20Public-Facing.pdf

  BACKGROUND

• Remmington NA, Fabrigar LR, Visser PS. Reexamining the circumplex model of affect. J Pers Soc Psychol. 2000 Aug;79(2):286-300. doi: 10.1037//0022-3514.79.2.286.

  PMID: 10948981 BACKGROUND

• Sindhusake D, Golding M, Newall P, Rubin G, Jakobsen K, Mitchell P. Risk factors for tinnitus in a population of older adults: the blue mountains hearing study. Ear Hear. 2003 Dec;24(6):501-7. doi: 10.1097/01.AUD.0000100204.08771.3D.

  PMID: 14663349 BACKGROUND

• Starcke K, Mayr J, von Georgi R. Emotion Modulation through Music after Sadness Induction-The Iso Principle in a Controlled Experimental Study. Int J Environ Res Public Health. 2021 Nov 26;18(23):12486. doi: 10.3390/ijerph182312486.

  PMID: 34886210 BACKGROUND

• Vernon D, Peryer G, Louch J, Shaw M. Tracking EEG changes in response to alpha and beta binaural beats. Int J Psychophysiol. 2014 Jul;93(1):134-9. doi: 10.1016/j.ijpsycho.2012.10.008. Epub 2012 Oct 17.

  PMID: 23085086 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

• Brandon Paul, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kay Wright-Whyte, MSc

CONTACT

4169795000; kww@torontomu.ca

George Chan, PhD

CONTACT

4169795000; george.chan@torontomu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 16, 2023
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data are available now and will be for 7 years post-data collection completion.
• Access Criteria: There are no specific access criteria for the individual participant data on the Open Science Framework. It is freely and openly available to anyone.

Locations

CA (1)