ARC synaptic adaptation therapy: A new treatment for tinnitus

• Register: ISRCTN
• Last refreshed on: 23 October 2023
• Main ID: ISRCTN18341063
• Date of registration: 30/03/2017
• Prospective Registration: No
• Primary sponsor: Bioacoustic LTD
• Public title: ARC synaptic adaptation therapy: A new treatment for tinnitus
• Scientific title: ARC synaptic stabilization: Synaptic adaptation therapy as a new treatment for tinnitus trial
• Date of first enrolment: 24/04/2016
• Target sample size: 38
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN18341063
• Study type: Interventional
• Study design: Double blind single centre randomised controlled trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Poland

Contacts

• Name: Adam Pabis

Key inclusion & exclusion criteria

Inclusion criteria:
1. Both women and men
2. Age between 18 and 60 years of age
3. Must be right-handed
4. Must suffer from permanent tinnitus
5. Tinnitus must not last longer than for two years
6. Only two persons with tinnitus lasting for more than 2 years may participate in the trial
7. Tinnitus may be tone or wide-band one
8. Tinnitus heard in head or ear
9. Movement or sight may modulate tinnitus
11. Have a high level of serotonin tested in the laboratory in serum or blood plasma (>100 µg/l )
12. Small difference in the HDL- LDL cholesterol units of the patient; it should be at the level of 1:1 or very similar (high level of BDNF protein)
14. Hearing loss in the range between 10 kHz and 20 kHz
15. Tinnitus occurs due to the model of increased synapse activity (Tinnitus does not require macroscopic tonotopic map reorganization)
16. Follows the recommendation referring to the diet and physical activity which notified to it before the clinical trial
17. Auditory canals must not be obstructed during the therapy, no inflammation of the middle ear before commencing of the treatment and during its course
18. Average loss of hearing of the patient noted on audiogram does not exceed the level of 70 dB for a single frequency
19. Apart from the gradual loss of hearing the patient had to experience also the sudden loss of hearing visible in the background of dead outer hair cells in the range from 10 to 20 kHz
20. Does not work in the noise
21. Does not suffer from depression, anxieties, sleep disorders

Exclusion criteria:
1. Suffers from hearing loss that starts already in the range of from 125 Hz to 10 kHz in one or both ears
2. Suffers from a chronic disease, such as diabetes, kidney failure, cancer
3. Tinnitus is pulsed or not continued
4. Model of nervous system plasticity, increased synchronization, which assumes that the nervous system of the patient underwent the neurons migration process or the reorganization of the auditory cortex, which additionally leads to auditory oversensitivity
5. Auditory Hyperacusis (a negative symptom of hidden hearing loss in the scope of proper hearing or increased synchronization model)
6. The hearing loss exceeds 70 dB of the single frequency
7. In audiogram, the patient manifests a dead zone of the inner ear (destroyed external and internal hair cells)
8. Partially or deaf in one or both ears
9. The auditory canal of the patient obstructed due to cerumen or inflammation of the middle ear
10. Serotonin level of the patient is lower than required.
11. Manifests metabolic disorders, which cannot be adjusted with diet and physical activity (hyperlipidemia), congenital heart disease, in spite of following the diet and physical activities there is a big difference between HDL and LDL cholesterol and high level of triglycerides
12. Works in noise
13. Suffers from depression, anxieties, sleep disorders
14. Does not want to follow the diet and physical activities


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Tinnitus
Ear, Nose and Throat
Tinnitus

Intervention(s)

Participants are randomly allocated to either the control group or the intervention group (this is done using a coin toss). Participants are given a synaptic adapter (tone generator) with a stimulation range that covers the range of sudden hearing loss and its intensity confirmed by pre-existing hearing and neurobiological studies. The device is non invasive ear canal headphone. The device is worn daily for eight to ten hours.

Control group: Those in the control group receive the placebo stimulation. They wear the same setting with a consistent tone, duration and frequency (Hz). The stimulation remains constant during the same time.

Intervention group: Participants start at the same tone, duration and frequency (Hz) stimulation as the placebo group but the signal consistently decreases over time (i.e. the interval between sequences increases each week) and the intensity in dB which dropped by three each week (reversal of gradual hearing loss).

The device is worn for four months (109 days). Participants are assessed for their reduction in tinnitus at baseline, and after the intervention period (after four months).

Primary Outcome(s)

Tinnitus reduction is measured by using a tinnitus patient questionnaire at baseline and 4 months

Secondary Outcome(s)

There are no secondary outcome measures.

Secondary ID(s)

7010426856

Source(s) of Monetary Support

Bioacoustic LTD Poland

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Approved 9/04/2016, Nicolaus Copernicus University [Uniwersytet Mikolaja Kopernika w Toruniu] Medical College Bioethics Committee (Ul. M. Sklodowskiej-Curie 9, 85-094 Bydgoszcz, Poland; [phone]; no email), ref: KB 336/2016

Results

• Results available: Yes
• Date Completed: 10/12/2016