Tinnitus Sound Therapy Using Mobile Application.

NCT06104865 | Unknown Early Phase 1 DMC

• 1 other identifier: phc56325
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Over the years Tinnitus Sound Therapy (TST) has been undergoing rigorous modification according to the availability of various technologies such as Hearing Aids, personal amplification devices, mp3 players, and now mobile phones. Now more than ever, it is a great opportunity to enhance accessibility, flexibility and engagement of TST as it is easy to personalize, provide tailored therapy program as well as obtaining feedback and real-time monitoring allows us to record progress of the program while keeping the cost low, which benefits to avoid purchasing personal amplification device or Hearing Aids, and hence allowing large number of people to access the service to improve the quality of life affected by Tinnitus. The offers by mobile phone applications are too huge to avoid as the interface has gaming elements, progress tracking, reminders, and support networks, therefore providing enjoyable experience. Integration of various multimodalities into a single platform including sound therapy, relaxation exercises and educational resources addresses both the auditory and psychological aspects of tinnitus. Our study focuses on personalized sound therapy. Real-time monitoring of progress and the effectiveness of such research will show potential to revolutionize the delivery of TST conveniently as a routine treatment for the patients that fit the inclusion criteria.

Conditions

Tinnitus

Keywords

Tinnitus; Chronic Tinnitus; Adults; Sound Therapy; Mobile Application; Relieve; Relief; Resound

Outcome Measures

Primary Outcomes (1)

• Measure the severity of Chronic tinnitus after intervention using THI scale of tinnitus measurement

  Tinnitus Handicap Inventory (THI) is a Self-reporting measure of the impact of tinnitus on the daily life. Three subscales: functional, emotional and catastrophic reactions. The participant will choose yes, sometimes, and no. A maximum of 100 can be scored and the greater the score, the greater the severity. An improvement of at least 20 points or more reflects clinically important change in the severity of tinnitus.

  6 months

Secondary Outcomes (1)

• Measure the severity of Chronic tinnitus after intervention using VAS scale of tinnitus measurement

  6 months

Study Arms (1)

Tinnitus Sound Therapy

EXPERIMENTAL

Resound Tinnitus Application, different sounds will be presented over a six months period of time on the speaker of the mobile handset in the background for 30 mins twice a day at least, loudness near but less than the tinnitus intensity itself.

Behavioral: Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application

Interventions

Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application BEHAVIORAL

Patient exposure to relieving sound(wind, rain, ocean waves, etc) of his own choice from the mobile phone application and using this effect with time to accommodate the brain to neglect the negative effects of tinnitus.

Tinnitus Sound Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults.
• Chronic tinnitus for more than 6 months.
• Subjective tinnitus.
• Tinnitus affecting quality of life, limiting daily life activities, and causing distress.
• Physically and mentally fit and able to fill in the questionnaires themselves.
• Persons who have a mobile phone with Android or iOS.

You may not qualify if:

• \- Intermittent tinnitus.
• Tinnitus not affecting quality of life, not limiting daily life activities, and not causing distress.
• Objective tinnitus.
• Severe or profound hearing loss.
• No device enabling the use of the application (Patient has no mobile phone).
• Vulnerable group of patients (Pregnant women, Patients with physical or mental disabilities, Patients older than 65 years, Children under 18 years, Prisoners, Refugees)
• Patients with physical disabilities that prevent the patients from using the mobile.

Sponsors & Collaborators

• Dr. Basel Samman: lead
• Primary Health Care Corporation, Qatar: collaborator

Related Links

• \- Effect of Different Sounds on the Treatment Outcome of Tinnitus Retraining Therapy Bong Jik Kim,1,2 Sung-Won Chung,1 Jae Yun Jung,1 and Myung-Whan Suhcorresponding author, Clin Exp Otorhinolaryngol. 2014 Jun; 7(2): 87-93. Published online 2014 May 21.
• Effectiveness of sound therapy in patients with tinnitus resistant to previous treatments: importance of adjustments, Flavia Alencar de Barros Suzuki, Fabio Akira Suzuki, Fernando Kaoru Yonamine, Ektor Tsuneo Onishi, Norma Oliveira Penido, PMID: 26541232
• Sound therapy (using amplification devices and/or sound generators) for tinnitus in adults Magdalena Sereda,corresponding author Jun Xia, Amr El Refaie, Deborah A Hall, and Derek J Hoare, Cochrane Database Syst Rev. 2018 Aug; 2018(8): CD013094. Publishe
• Efficacy of TRT Using Noise Presentation from Mobile Phone Md. Noorain Alam, Manish Gupta, Sanjay Munjal \& Naresh K. Panda, Indian Journal of Otolaryngology and Head \& Neck Surgery volume 69, pages 333-337 (2017)Cite this article,
• Effectiveness of tinnitus therapy using a mobile application, Eur Arch Otorhinolaryngol. 2022; 279(3): 1257-1267. Published online 2021 Mar 30. , Justyna Kutyba,corresponding author1 Elżbieta Gos,1 Wiesław Wiktor Jędrzejczak
• American Tinnitus Association, Tinnitus Handicap Inventory (THI; Newman et al., 1996),
• Visual Analogue Scales as a Tool for Initial Assessment of Tinnitus Severity: Psychometric Evaluation in a Clinical Population, Danuta Raj-Koziak, Elzbieta Gos, Weronika Swierniak, Joanna J Rajchel, Lucyna Karpiesz, Iwona Niedzialek, Elzbieta Wlodarczyk,

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

• Basel M Samman, Doctor

  Ministry of Public Health Qatar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basel M Samman, Doctor

CONTACT

0097466170645; bsamman@phcc.gov.qa

Sadiqunnisa Kutagulla, Mrs

CONTACT

97450524136; skutagulla@phcc.gov.qa

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Otolaryngology Cosultant

Model Details: Single arm clinical trial

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share