TinnitusEarly Phase 1TSTNCT06104865
Tinnitus Sound Therapy Using Mobile Application.
A Early Phase 1 study testing Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application in people with Tinnitus, run by Dr. Basel Samman.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sound Therapy for Adults With Chronic Tinnitus, Using ((Resound Tinnitus Relief)) Mobile Application, in Qatar, 2023.
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.
Read the 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.
Sound therapy is the use of an instrument (Hearing Aid, Mobile, Laptop …) to generate a sound that the patient will hear as a back ground during the daily life activities, for a certain time on a daily basis for the period of several months, this sound volume is set to be just less than the patient's own tinnitus. The nature of this sound can be a wide band noise (white noise), a variety of nature sounds (River, waterfall, Wind, Birds …), music, etc. The aim is to distract and habituate the patient from focusing on his tinnitus and enable him/her to focus more on the daily life activities so that the tinnitus will no longer be an obstacle preventing the patient from enjoying life.
Modalities of Sound Therapy generators include:
Environmental enrichment devices (Tabletop sound machines generate, CD recordings or personal audio players generate music, speakers, Fans, TV, radio, Smartphones, or tablets with apps specifically created to produce a variety of sounds that aid in tinnitus relief). Hearing aids (Digital signal processing devices allow for flexibility in manipulating the acoustic signal based on the patient's hearing loss severity and audiometric configuration promoting a (masking/partial masking effect), Sound generators (Ear-level sound generators that produce broadband noise(s) (eg, white noise, pink noise) are a choice for patients with normal or near-normal audiometric thresholds, available in in-the-ear or behind-the-ear styles), Combination tinnitus instruments (Contain hearing aid circuit and noise-producing circuit in the same device may be connected by Bluetooth to any device like Laptops or Mobiles).
Our aim in the study is to use the Mobile, with a specific application (RESOUND TINNITUS RELIEF), to generate the treatment sound, this application has a variety of nature sounds (Birds, Bubbles, Crickets, Brook, Fire, Rain, Waves, Wind …), so the patient will choose the sound, which is most relieving one for him, to be used as his own specific treating sound. The patient will listen to this sound and keep it as a background for at least 60 min per day, for a period of 6 months daily. The same application (RESOUND TINNITUS RELIEF) was used for a Sound Therapy in a previous research.
In recent years, many applications on mobile phones have been developed and introduced to perform calming or masking effects for tinnitus patients.
Many studies published so far related to conventional sound therapy using an external device such as an amplification device or tinnitus masker reports to reduce the effect of tinnitus. Kim et al, (2014), used Mp3 player to provide sound therapy with different stimuli such as Narrow Band Noise (NBN), Wide Band Noise (WBN) and mixed Noise and reported improvement on Tinnitus Handicap Inventory (THI) and visual-analogue scale (VAS) values. Additionally in a study, Suziki et al. (2016) reported that there was reduction in the THI values when individual customized approach was used. However, in a review conducted by Sereda et al. (2018) showed that one type of device was not better than the other type. Alam et al (2017), in a study reported that the presentation of masking stimuli using mobiles for 6 months had a significant success in reducing the severity of tinnitus and improvement in quality of life. A recent study done by Kutyba et al. (2021) reports a decrease in tinnitus symptoms measured by THI and TFI both when a continuous use of sound therapy for 6 months was presented through a mobile application (RESOUND TINNITUS RELIEF). To further conclude, the same Kutyba et al(2022) continued the study and reported to achieve lower negative emotions and reduced overall tinnitus severity. The Tinnitus progress during the sound treatment was evaluated by two inventory questionnaires, Tinnitus Handicap Inventory (THI) and visual-analogue scale (VAS), these two questionnaires aim to study the Patient's sensation of his own tinnitus and the psychological effect of tinnitus on the patient's daily life activities (DLA), before, During (after 3 months of the start of study), and after the end of the Sound Treatment.
Even though significant data is available from these and many other researches, there is a lack of objective measurement of time the mobile apps were used by the patients at home in all the studies, there was also lack of information of usage of other forms of treatment during the researched.
Our study aims to evaluate effectiveness of mobile app alone (RESOUND TINNITUS RELIEF), to provide sound therapy for Tinnitus patients, and then evaluate the treatment results by using the THI and the VAS tinnitus evaluation questionnaires.
- Conditions
- Tinnitus
- Being tested
- Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application
- Keywords
- Tinnitus, Chronic Tinnitus, Adults, Sound Therapy, Mobile Application, Relieve, Relief, Resound
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Measure the severity of Chronic tinnitus after intervention using VAS scale of tinnitus measurement
The visual analog scale (VAS) is a validated, subjective measure of Tinnitus. Scores are recorded by making a handwritten mark on a 10-cm line scale that represents a continuum between "no tinnitus = score 0" and "worst tinnitus = score 10.".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Basel Samman
- Sponsor type
- Other government
- Collaborators
- Primary Health Care Corporation, Qatar
- Responsible party
- Sponsor-investigator, Dr. Basel Samman, Primary Health Care Corporation, Qatar
- Investigators
- Basel M Samman, Doctor, Principal investigator, Ministry of Public Health Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104865
- Sponsor's protocol ID
- phc56325
- Acronym
- TST
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound Therapy for Adults With Chronic Tinnitus, Using ((Resound Tinnitus Relief)) Mobile Application, in Qatar, 2023.
- ClinicalTrials.gov ID
- NCT06104865
- Acronym / sponsor ID
- TST / phc56325
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Chronic Tinnitus, Adults, Sound Therapy, Mobile Application, Relieve, Relief, Resound
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Basel SammanOther government
- Collaborators
- Primary Health Care Corporation, Qatar
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Sound therapy is the use of an instrument (Hearing Aid, Mobile, Laptop …) to generate a sound that the patient will hear as a back ground during the daily life activities, for a certain time on a daily basis for the period of several months, this sound volume is set to be just less than the patient's own tinnitus. The nature of this sound can be a wide band noise (white noise), a variety of nature sounds (River, waterfall, Wind, Birds …), music, etc. The aim is to distract and habituate the patient from focusing on his tinnitus and enable him/her to focus more on the daily life activities so that the tinnitus will no longer be an obstacle preventing the patient from enjoying life.
Modalities of Sound Therapy generators include:
Environmental enrichment devices (Tabletop sound machines generate, CD recordings or personal audio players generate music, speakers, Fans, TV, radio, Smartphones, or tablets with apps specifically created to produce a variety of sounds that aid in tinnitus relief). Hearing aids (Digital signal processing devices allow for flexibility in manipulating the acoustic signal based on the patient's hearing loss severity and audiometric configuration promoting a (masking/partial masking effect), Sound generators (Ear-level sound generators that produce broadband noise(s) (eg, white noise, pink noise) are a choice for patients with normal or near-normal audiometric thresholds, available in in-the-ear or behind-the-ear styles), Combination tinnitus instruments (Contain hearing aid circuit and noise-producing circuit in the same device may be connected by Bluetooth to any device like Laptops or Mobiles).
Our aim in the study is to use the Mobile, with a specific application (RESOUND TINNITUS RELIEF), to generate the treatment sound, this application has a variety of nature sounds (Birds, Bubbles, Crickets, Brook, Fire, Rain, Waves, Wind …), so the patient will choose the sound, which is most relieving one for him, to be used as his own specific treating sound. The patient will listen to this sound and keep it as a background for at least 60 min per day, for a period of 6 months daily. The same application (RESOUND TINNITUS RELIEF) was used for a Sound Therapy in a previous research.
In recent years, many applications on mobile phones have been developed and introduced to perform calming or masking effects for tinnitus patients.
Many studies published so far related to conventional sound therapy using an external device such as an amplification device or tinnitus masker reports to reduce the effect of tinnitus. Kim et al, (2014), used Mp3 player to provide sound therapy with different stimuli such as Narrow Band Noise (NBN), Wide Band Noise (WBN) and mixed Noise and reported improvement on Tinnitus Handicap Inventory (THI) and visual-analogue scale (VAS) values. Additionally in a study, Suziki et al. (2016) reported that there was reduction in the THI values when individual customized approach was used. However, in a review conducted by Sereda et al. (2018) showed that one type of device was not better than the other type. Alam et al (2017), in a study reported that the presentation of masking stimuli using mobiles for 6 months had a significant success in reducing the severity of tinnitus and improvement in quality of life. A recent study done by Kutyba et al. (2021) reports a decrease in tinnitus symptoms measured by THI and TFI both when a continuous use of sound therapy for 6 months was presented through a mobile application (RESOUND TINNITUS RELIEF). To further conclude, the same Kutyba et al(2022) continued the study and reported to achieve lower negative emotions and reduced overall tinnitus severity. The Tinnitus progress during the sound treatment was evaluated by two inventory questionnaires, Tinnitus Handicap Inventory (THI) and visual-analogue scale (VAS), these two questionnaires aim to study the Patient's sensation of his own tinnitus and the psychological effect of tinnitus on the patient's daily life activities (DLA), before, During (after 3 months of the start of study), and after the end of the Sound Treatment.
Even though significant data is available from these and many other researches, there is a lack of objective measurement of time the mobile apps were used by the patients at home in all the studies, there was also lack of information of usage of other forms of treatment during the researched.
Our study aims to evaluate effectiveness of mobile app alone (RESOUND TINNITUS RELIEF), to provide sound therapy for Tinnitus patients, and then evaluate the treatment results by using the THI and the VAS tinnitus evaluation questionnaires.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tinnitus Sound Therapy | Experimental | Behavioral: Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile applicationResound 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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.
Key exclusion criteria (7 listed)
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile applicationPatient 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. | Behavioural | Tinnitus Sound Therapy |
Primary outcome
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.
1 secondary outcome
Measure the severity of Chronic tinnitus after intervention using VAS scale of tinnitus measurement
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- \- 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.Link provided by the sponsor.
- 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: 26541232Link provided by the sponsor.
- 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. PublisheLink provided by the sponsor.
- 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,Link provided by the sponsor.
- 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 JędrzejczakLink provided by the sponsor.
- American Tinnitus Association, Tinnitus Handicap Inventory (THI; Newman et al., 1996),Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Recruiting
Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Tinnitus, Tinnitus, Bilateral
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Active, not recruitingPhase 2
TNF-α Treatment of Blast-Induced Tinnitus
Tinnitus, Noise Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basel M Samman, Doctor principal investigator
Ministry of Public Health Qatar
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tinnitus Sound Therapy using (Resound Tinnitus relief) mobile application in people with Tinnitus, run by Dr. Basel Samman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basel M Samman, Doctor (0097466170645, bsamman@phcc.gov.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the severity of Chronic tinnitus after intervention using THI scale of tinnitus measurement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.