Clinical trials: Acoustic Stimulation
Insomnia, Sleep Initiation and Maintenance Disorders
Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia
This study is a multicenter, single-arm, prospective clinical trial designed to observe the long-term safety and effectiveness of the digital medical device BELL-001 in patients diagnosed with insomnia.
- Trial name
- NCT07582809
- Testing
- BELL-001 Digital Therapeutic
- Where
- 3 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- BELL Therapeutics Inc.
Chronic Tonal Tinnitus
Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely.
- Trial name
- NCT00927121
- Testing
- Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
- Where
- Germany
- Volunteers
- 63 people
- Sponsor
- ANM Adaptive Neuromodulation GmbH
Hearing Loss
Safety and Effectiveness of the MED-EL Electric-Acoustic System
The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic…
- Trial name
- EAS (NCT00747435)
- Testing
- Electric Acoustic System
- Where
- 14 sites in United States
- Volunteers
- 73 people
- Sponsor
- Med-El Corporation
Hearing Loss, Cochlear, Neurinoma of the Acoustic Nerve
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.
- Trial name
- NeuriStim (NCT02948790)
- Testing
- Neuristim, Cochlear implant
- Where
- 4 sites in France
- Volunteers
- 17 people
- Sponsor
- Oticon Medical
Tinnitus
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear.
- Trial name
- NCT01176734
- Testing
- tVNS-Device
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- cerbomed GmbH
Cochlear Implant
Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery.
- Trial name
- NCT02966379
- Testing
- cochlear implantation
- Where
- 8 sites in France
- Volunteers
- 17 people
- Sponsor
- Oticon Medical
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Cerebral Arterial Diseases
Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation
Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.
- Trial name
- NCT03632564
- Testing
- REVIVIEW dichoptic audio-visual stimulation
- Where
- Israel
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Visior Technologies Ltd.
Sleep Deprivation, Insufficient Sleep Syndrome
Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation
This study is a randomized, single-blind, sham-controlled pilot cross-over trial comparing the feasibility, and efficacy of 2 nights of in lab use with active versus sham conditions in adults with sleep restricted schedules.
- Conditions
- Sleep Deprivation, Insufficient Sleep Syndrome, Healthy
- Trial name
- NCT03600194
- Testing
- PowerSleep Stim, Northwestern Stim
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Philips Respironics
Hearing Loss, Sensorineural
Electric-Acoustic Stimulation Extended Follow-up Post Approval Study
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.
- Trial name
- NCT03031678
- Testing
- Electric-Acoustic Stimulation (EAS) Cochlear Implant System
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Med-El Corporation
MCI-AD, Early Stage Alzheimer's Disease, Alzheimer s Disease
Home-Based Closed-Loop Auditory Stimulation to Enhance Slow-Wave Activity in MCI Due to Alzheimer's Disease: A Proof-of-Concept Study
This proof-of-concept study explores whether long-term home-based closed-loop auditory stimulation during sleep enhances slow-wave activity (SWA) and yields preliminary efficacy signals in patients with amnestic mild cognitive…
- Conditions
- MCI-AD, Early Stage Alzheimer's Disease, Alzheimer s Disease, Mild Cognitive Impairment (MCI) Amnestic, AD
- Trial name
- Nana-Home (NCT07672977)
- Testing
- Closed-Loop Auditory Stimulation
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Bitbrain
Neuromyelitis Optica Spectrum Disorder
Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder
The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.
- Trial name
- aNiMatO (NCT06374264)
- Testing
- MR-C-014
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedRhythms, Inc.
Cochlear Hearing Loss
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound…
- Trial name
- NCT06301568
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Advanced Bionics AG
Mild Cognitive Impairment (MCI), Amnestic Mild Cognitive Impairment - aMCI
Auditory Stimulation During Sleep to Enhance Long-Term Memory in Amnestic MCI
This study aims to evaluate the efficacy and safety of Elevvo AudiStim, a sleep auditory stimulation device, as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI).
- Conditions
- Mild Cognitive Impairment (MCI), Amnestic Mild Cognitive Impairment - aMCI, Alzheimer or Mild Cognitive Impairment
- Trial name
- NCT07402590
- Testing
- Auditory Stimulation
- Where
- Spain
- Volunteers
- 37 people
- Sponsor
- Bitbrain
Hearing Loss, Partial Deafness
Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with…
- Conditions
- Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases
- Trial name
- NCT02189798
- Testing
- HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
- Where
- 11 sites in United States
- Volunteers
- 67 people
- Sponsor
- Advanced Bionics
Tinnitus, Hyperacusis
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36…
- Trial name
- CALM (NCT00730834)
- Testing
- Oasis
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Neuromonics, Inc.
Tinnitus
The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus.
- Trial name
- NCT02648542
- Testing
- Compensatory auditory stimulation, transcranial direct current stimulation, Combined CAS and tDCS
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Soterix Medical
Chronic Stroke
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
The purpose of this trial is to assess engagement, efficacy, durability, and impact on health care resource utilization of MR-001 in persons with chronic stroke who have a gait deficit after in-home/community use.
- Trial name
- OrcHESTRAS (NCT06051539)
- Testing
- MR-001
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- MedRhythms, Inc.
Insomnia, Sleep Initiation and Maintenance Disorders
Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia
This study is a multicenter, randomized, double-blind, sham-controlled clinical investigation designed to evaluate the effectiveness and safety of BELL-001, a digital therapeutic developed to improve symptoms of insomnia.
- Trial name
- SERENE (NCT07295431)
- Testing
- BELL-001 Digital Therapeutic
- Where
- 6 sites in South Korea
- Volunteers
- 116 people
- Sponsor
- BELL Therapeutics Inc.
Sleep, Sleep Disturbance
Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset.
- Trial name
- SLEEPFAST (NCT05743114)
- Testing
- Elemind Neuromodulation (ENMod)
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Elemind Technologies, Inc.