Sound Therapy for Adults With Chronic Tinnitus, Using ((Resound Tinnitus Relief)) Mobile Application, in Qatar, 2023.
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Measure the severity of Chronic tinnitus after intervention using THI scale of tinnitus measurement
Study Overview
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.
Detailed Description
Tinnitus is the sound perception of ((ringing, hissing, buzzing, etc.)), in the absence of an external stimulus. If persistent and intolerable or sufficiently bothersome, tinnitus can cause functional impairment in thought processing, emotions, hearing, sleep, and concentration, all of which can affect quality of life. The negative effect on quality of life due to chronic tinnitus has been reported to adversely affect all 5 measures of validated health related quality of life surveys including mobility, self-care, performance of usual activities, pain and/or discomfort, and anxiety/depression.
The prevalence of tinnitus ranges from 8% to 25.3% of the US population whereas in other nations similarly prevalence ranges from 4.6% to 30%. The severity of tinnitus is higher with increasing age and is more prevalent in men (10.5%) than in women (8.8%). In some populations, it's even more prevalent than back and neck pain, knee problems and diabetes milletus.
The management of Tinnitus is difficult and usually fails with the variety of treatment modality, as yet no drug has been approved for tinnitus by a regulatory body (e.g. the European Medicines Agency or US Food and Drug Administration), hens there is a need for a method that gathers the cognitive and behavioral therapy to relieve the Tinnitus, and this is where the Tinnitus Sound Therapy fits in.
The American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) published its multidisciplinary, evidence-based practice guidelines for the management of tinnitus, a briefing of the AAO-HNSF recommendations regarding Tinnitus treatment options:
Clinicians should not routinely recommend medications like antidepressants, anticonvulsants, anxiolytics, or intratympanic medications for a primary indication of treating persistent, bothersome tinnitus, Clinicians should not recommend dietary supplements like Ginkgo biloba, melatonin, zinc ... for treating patients with persistent, bothersome tinnitus, no recommendation can be made regarding the effect of acupuncture in patients with persistent bothersome tinnitus, Clinicians should not recommend transcranial magnetic stimulation for the routine treatment of patients with persistent, bothersome tinnitus, Clinicians should recommend a hearing aid evaluation for patients with hearing loss and persistent, bothersome tinnitus, Clinicians may recommend sound therapy and cognitive behavioral therapy to patients with persistent bothersome tinnitus.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •- 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.
Exclusion Criteria
- •- 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.
Arms & Interventions
Tinnitus Sound Therapy
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.
Intervention: Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application (Behavioral)
Outcomes
Primary Outcomes
Measure the severity of Chronic tinnitus after intervention using THI scale of tinnitus measurement
Time Frame: 6 months
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.
Secondary Outcomes
- Measure the severity of Chronic tinnitus after intervention using VAS scale of tinnitus measurement(6 months)
Investigators
Dr. Basel Samman
Otolaryngology Cosultant
Primary Health Care Corporation, Qatar