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Hearing Loss clinical trials

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NCT ID: NCT06467526 Not yet recruiting - Sudden Hearing Loss Clinical Trials

Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

Sudden sensorineural hearing loss (SSNHL) is diagnosed when there's a sudden drop in hearing of at least 30 decibels across three consecutive frequencies, emerging within up to 72 hours. In clinical settings, steroids are the predominant treatment for SSNHL. However, the outcomes for patients undergoing steroid therapy for SSNHL can differ substantially. Moreover, a systematic review of randomized clinical trials has found no conclusive evidence pinpointing an effective treatment for SSNHL. Hydroxychloroquine, a derivative of chloroquine, is a medication that has gained attention for its potential role in modulating the immune response. We aim to see if hydroxychloroquine could augment hearing recovery in SSNHL under steroid treatment and to evaluate the safety of hydroxychloroquine in the treatment of SSNHL patients. We plan to enroll 80 SSNHL patients who received oral steroid therapy and randomize them into an experimental group (hydroxychloroquine with prednisolone, 40 patients) and a control group (prednisolone, 40 patients). The primary endpoint will be the change in pure tone audiogram (PTA) in the affected ear from screening until 3 months. The secondary endpoints will be the change in word recognition score and the change in bilateral tinnitus severity after treatment. Any side effects will be recorded to ensure the safety of this clinical trial.

NCT ID: NCT06461520 Not yet recruiting - Clinical trials for Hearing Impaired Children

Effects of Maze Balance Board Training on Balance in Children With Hearing Impairment.

Start date: June 16, 2024
Phase: N/A
Study type: Interventional

The majority of children's everyday activities need balance, which is the complex ability to maintain, obtain, or restore the condition of balance of the body when a child is standing still, getting ready to move, or getting ready to stop moving. Integration of several sensory, motor, and biomechanical inputs is necessary for balance. Nonetheless, alterations in certain sensory systems (such as visual, somatosensory, and vestibular) may result in imbalances inside the body. Previous research has demonstrated that children and adolescents with hearing impairments are more likely to experience balance and/or motor deficits as a result of vestibular system damage, which increases their risk of developing motor and balance issues. Additionally, research has demonstrated a link between hearing loss and a higher risk of all-cause death, maybe through physical activity-related factors including balance and mobility. Combining maze control training with traditional physical therapy's proprioceptive exercises tests your balance and improves your stability overall.

NCT ID: NCT06453343 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

BULLS-I
Start date: July 2024
Phase: N/A
Study type: Interventional

This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.

NCT ID: NCT06451757 Not yet recruiting - Clinical trials for Mitochondrial Diseases

KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases

KH176-301
Start date: January 2, 2025
Phase: Phase 3
Study type: Interventional

The KHENERFIN study is investigating whether the study medicine, sonlicromanol, is able to improve symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able improve physical abilities of people living with mitochondrial disease, such as balance control and lower limb skeletal muscle strength. For this study, the effects of sonlicromanol are compared with those from a placebo (study medication that looks like the actual study medicine but contains no active medicine). The study medicine (or placebo) is a powder that is dissolved in water and must be taken twice daily during the treatment period of 52 weeks. Additionally, the study evaluates the efficacy of sonlicromanol on selected secondary and exploratory outcome measures, as well as the safety and tolerability of sonlicromanol after 52 weeks of treatment with sonlicromanol.

NCT ID: NCT06437054 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss

Start date: February 15, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

NCT ID: NCT06424262 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)

DETECT
Start date: June 2024
Phase: N/A
Study type: Interventional

This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.

NCT ID: NCT06420921 Not yet recruiting - Clinical trials for Cochlear Hearing Loss

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

MIRACLE
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with cochlear implant(s). The measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis. Researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment. Participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement.

NCT ID: NCT06406088 Not yet recruiting - Clinical trials for Hearing Impaired Children

EarGenie MVP Performance Evaluation

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound levels (detection) and speech sound contrasts (discrimination).

NCT ID: NCT06400992 Not yet recruiting - Hearing Loss Clinical Trials

Investigation of Sky Automatic Technologies in Pediatrics

SKY-MARVEL
Start date: June 2024
Phase: N/A
Study type: Interventional

The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance

NCT ID: NCT06377215 Not yet recruiting - Aging Clinical Trials

Understanding Aided Speech Perception in Noise

Start date: April 15, 2024
Phase:
Study type: Observational

The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.