X: represents the time points when each questionnaire was sent to participants; GHQ-12: General Health Questionnaire-12; ISI: Insomnia Severity Index; PCL-5 short version: PTSD Checklist for DSM-5 short version; PHQ-15: Patient Health Questionnaire-15; SWLS: Satisfaction with Life Scale; TFI: Tinnitus Functional Index.
Declarations
Acknowledgments
While no direct funding was provided for the makers of the TinniSoothe device to support this project, we would like to acknowledge their generous support in discounting the TinniSoothe devices to the study team. We extend our deepest gratitude to all the veterans who participated in this research.
Author contributions
PH: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. DM: Conceptualization, Supervision, Writing—review & editing. Both authors read and approved the final submitted version.
Conflicts of interest
The authors declare that they have no conflicts of interest. The authors confirm that the makers of the TinniSoothe device mentioned in the Acknowledgments have no conflicts of interest with the authors, and had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Ethical approval
The study in this protocol was reviewed and approved by the local ethics committee of King’s College London (LRS/RGO-24/25-48840) and was registered as a clinical trial (registration number: NCT06905158). This study complies with the 2024 Declaration of Helsinki.
Consent to participate
Informed consent to participate in the study will be obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
The data that will support the findings of this study are not yet available as the study is ongoing. Upon completion, the data will be made available by the corresponding author upon reasonable request.
Funding
This study is funded by the Watson Trust (reference number: [CSGN5863]). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.
References
Wang H, Tang D, Wu Y, Zhou L, Sun S. The state of the art of sound therapy for subjective tinnitus in adults.Ther Adv Chronic Dis. 2020;11:2040622320956426. [DOI] [PubMed] [PMC]
Folmer RL, Theodoroff SM, Martin WH, Shi Y. Experimental, controversial, and futuristic treatments for chronic tinnitus.J Am Acad Audiol. 2014;25:106–25. [DOI] [PubMed]
MacGregor AJ, Joseph AR, Dougherty AL. Prevalence of Tinnitus and Association with Self-Rated Health among Military Personnel Injured on Combat Deployment.Mil Med. 2020;185:e1608–14. [DOI] [PubMed]
Baguley DM, Fagelson M, editors. Tinnitus: Clinical and research perspectives.In: Tinnitus in military and veteran populations. San Diego (CA): Plural Publishing, Inc.; 2016. pp. 75–88.
Jastreboff PJ. Phantom auditory perception (tinnitus): mechanisms of generation and perception.Neurosci Res. 1990;8:221–54. [DOI] [PubMed]
Folmer RL, McMillan GP, Austin DF, Henry JA. Audiometric thresholds and prevalence of tinnitus among male veterans in the United States: data from the National Health and Nutrition Examination Survey, 1999–2006.J Rehabil Res Dev. 2011;48:503–16. [DOI] [PubMed]
Reavis KM, Henry JA, Marshall LM, Carlson KF. Prevalence of self-reported depression symptoms and perceived anxiety among community-dwelling U.S. adults reporting tinnitus.Perspect ASHA Spec Interest Groups. 2020;5:959–70. [DOI]
Henry JA, Griest SE, Blankenship C, Thielman EJ, Theodoroff SM, Hammill T, et al. Impact of Tinnitus on Military Service Members.Mil Med. 2019;184:604–14. [DOI] [PubMed]
Musleh A, Alharthy AKH, Alzahrani MYM, Bin Maadhah SA, Al Zehefa IA, AlQahtani RY, et al. Psychological Impact and Quality of Life in Adults With Tinnitus: A Cross-Sectional Study.Cureus. 2024;16:e51976. [DOI] [PubMed] [PMC]
Carlson KF, Gilbert TA, O’Neil ME, Zaugg TL, Manning CA, Kaelin C, et al. Health Care Utilization and Mental Health Diagnoses Among Veterans With Tinnitus.Am J Audiol. 2019;28:181–90. [DOI] [PubMed]
McFerran DJ, Stockdale D, Holme R, Large CH, Baguley DM. Why Is There No Cure for Tinnitus?Front Neurosci. 2019;13:802. [DOI] [PubMed] [PMC]
McFerran D, Hoare DJ, Carr S, Ray J, Stockdale D. Tinnitus services in the United Kingdom: a survey of patient experiences.BMC Health Serv Res. 2018;18:110. [DOI] [PubMed] [PMC]
Lee HY, Jung DJ. Recent Updates on Tinnitus Management.J Audiol Otol. 2023;27:181–92. [DOI] [PubMed] [PMC]
Liu H, Zhang J, Yang S, Wang X, Zhang W, Li J, et al. Efficacy of sound therapy interventions for tinnitus management: A protocol for systematic review and network meta-analysis.Medicine (Baltimore). 2021;100:e27509. [DOI] [PubMed] [PMC]
Deshpande AK, Bhatt I, Rojanaworarit C. Virtual reality for tinnitus management: a randomized controlled trial.Int J Audiol. 2022;61:868–75. [DOI] [PubMed]
Lelic D, Caporali S, Parker D, Nielsen J, Balling LW. Impact of a combination sound therapy on tinnitus distress: an exploratory one-year longitudinal study.Front Audiol Otol. 2024;2:1322596. [DOI]
Zhao W, Berger VW, Yu Z. The asymptotic maximal procedure for subject randomization in clinical trials.Stat Methods Med Res. 2018;27:2142–53. [DOI] [PubMed]
Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, et al. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus.Ear Hear. 2012;33:153–76. [DOI] [PubMed]
Goldberg D, Williams P. A user’s guide to the General Health Questionnaire. Windsor: NFER-Nelson; 1988.
Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response.Sleep. 2011;34:601–8. [DOI] [PubMed] [PMC]
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale.J Pers Assess. 1985;49:71–5. [DOI] [PubMed]
Zuromski KL, Ustun B, Hwang I, Keane TM, Marx BP, Stein MB, et al. Developing an optimal short-form of the PTSD Checklist for DSM-5 (PCL-5).Depress Anxiety. 2019;36:790–800. [DOI] [PubMed] [PMC]
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire.JAMA. 1999;282:1737–44. [DOI] [PubMed]
Chandra N, Chang K, Lee A, Shekhawat GS, Searchfield GD. Psychometric Validity, Reliability, and Responsiveness of the Tinnitus Functional Index.J Am Acad Audiol. 2018;29:609–25. [DOI] [PubMed]
Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application.Hear Res. 2016;334:58–64. [DOI] [PubMed]
Wojujutari AK, Idemudia ES, Ugwu LE. The evaluation of the General Health Questionnaire (GHQ-12) reliability generalization: A meta-analysis.PLoS One. 2024;19:e0304182. [DOI] [PubMed] [PMC]
Picardi A, Abeni D, Pasquini P. Assessing psychological distress in patients with skin diseases: reliability, validity and factor structure of the GHQ-12.J Eur Acad Dermatol Venereol. 2001;15:410–7. [DOI] [PubMed]
Hybelius J, Kosic A, Salomonsson S, Wachtler C, Wallert J, Nordin S, et al. Measurement Properties of the Patient Health Questionnaire-15 and Somatic Symptom Scale-8: A Systematic Review and Meta-Analysis.JAMA Netw Open. 2024;7:e2446603. [DOI] [PubMed] [PMC]
