Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06104865 |
| Other study ID # |
phc56325 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
July 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Primary Health Care Corporation, Qatar |
| Contact |
Basel M Samman, Doctor |
| Phone |
0097466170645 |
| Email |
bsamman[@]phcc.gov.qa |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
