Clinical trials: Cochlear Synaptopathy
Seneorineural Deafness, Sudden Sensorineural Hearing Loss
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage…
- Trial name
- NCT06249919
- Testing
- NS101
- Where
- 16 sites in South Korea
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Neuracle Science Co., LTD.
Hearing Loss, Sensorineural, Cochlear Synaptopathy
Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy
This study investigates a newly developed test, The CochSyn test that can quantify cochlear synaptopathy (CS) (a new type of sensorineural hearing loss (SNHL)) earlier than the current golden standard pure-tone audiogram.This…
- Conditions
- Hearing Loss, Sensorineural, Cochlear Synaptopathy, Cochlear Hearing Loss
- Trial name
- EarDiTech (NCT06114680)
- Testing
- CochSyn test prototype, Universal Smart Box (USB)
- Where
- Belgium
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- University Ghent
Hearing Loss
Fundamental and Clinical Study of Cochlear Synaptopathy
In humans, surface electrophysiological recording of the cochlear nerve in response to a sound stimulus provides information about the integrity and function of synapses (synaptic transmission) and nerve fibre function.
- Trial name
- FunCoSy (NCT06556160)
- Testing
- near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
- Where
- France
- Volunteers
- 19 people
- Sponsor
- CHU de Reims
Tinnitus, Bilateral, Cochlear Synaptopathy
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
The goal of this clinical trial is to investigate if paliroden (CIL001) is safe and can help treat cochlear synaptopathy in adult participants 18-75 years of age with normal hearing thresholds and normal cognition who exhibit…
- Trial name
- REACT (NCT07826507)
- Testing
- paliroden (CIL001)
- Volunteers
- 60 people
- Sponsor
- Cilcare SAS
Hearing Loss, Sensorineural, Cochlear Hearing Loss
Evaluation of the CochSyn Device in Clinical Practice
This study investigates a new type of auditory evoked brain potentials for the quantification and classification of peripheral hearing damage (The CochSyn Test).
- Conditions
- Hearing Loss, Sensorineural, Cochlear Hearing Loss, Cochlear Synaptopathy, DFNA9
- Trial name
- Earditech 2 (NCT07091071)
- Testing
- CochSyn device
- Where
- 3 sites in Belgium
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University Ghent
Structure Cochlea, Temporal Envelope Cochlea
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound.
- Trial name
- CosySpeech (NCT06499584)
- Testing
- near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
- Where
- France
- Volunteers
- 20 people
- Sponsor
- CHU de Reims
Sensorineural Hearing Loss
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
- Trial name
- NCT04462198
- Testing
- PIPE-505
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Hidden Hearing Loss, Cochlear Synaptopathy
Relationship Between LS Chirp ABR and Speech-in-Noise Skills in Hidden Hearing Loss
It is known that the underlying problem in Hidden Hearing Loss (HHL) is cochlear synaptopathy (CS) and that low-spontaneous-rate auditory nerve fibers play an important role in this pathology.
- Trial name
- NCT07230236
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Hidden Hearing Loss
Hidden Hearing Loss in Older Adults
The goal of this observational study is to investigate whether speech-in-noise perception deficits in older adults aged 60 years or older with objectively normal hearing thresholds are due to impaired ability of processing…
- Trial name
- NCT07646119
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Cochlear Synaptopathy
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes.
- Trial name
- RESPLAND (NCT07472907)
- Testing
- CIL001 (Paliroden)
- Volunteers
- 135 people
- Sponsor
- Cilcare SAS