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Hearing Loss clinical trials

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NCT ID: NCT06420037 Recruiting - Clinical trials for Hearing Loss, Sensorineural

The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70 hearing aids. The main questions it aims to answer are: Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile? The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids. The study will consist of three groups: one control group and two groups where one different feature will be modified. Participants will be tested at baseline measurement, including: - screening tests - audiological tests - questionnaires - cognitive tests - real-ear-measurement Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration.

NCT ID: NCT06418321 Recruiting - Clinical trials for Hearing Loss, Age-Related

Early Identification of Age-related Hearing Impairment

Start date: April 4, 2024
Phase:
Study type: Observational

The need for future hearing rehabilitation is enormous. World Health Organization (WHO 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. Currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process.

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: NCT06402994 Recruiting - Hearing Loss Clinical Trials

Automated Measures of Speech Intelligibility Using Brain Wave Recordings

CORGEE
Start date: February 23, 2024
Phase:
Study type: Observational

Hearing loss is one of the most prevalent impairments in the world. The World Health Organization estimates that as of 2020, around 466 million people worldwide are affected by disabling hearing loss, of which 34 million are children. Without appropriate diagnosis and treatment, hearing impairment can cause difficulties with communication, learning, social-emotional functioning, employment and quality of life. Early intervention is especially important for children, for whom unaddressed hearing loss has been proven to affect speech and language development, educational attainments, and social skills. Through early detection and interventions many of these impacts can be mitigated, highlighting the importance of accurate hearing diagnostics. Evaluation of speech intelligibility is a fundamental component of hearing assessment and rehabilitation. The current gold standard in measuring speech intelligibility relies heavily on behavioural tests. While these tests are reliable and fast in healthy adults, it is challenging to assess speech intelligibility for patients who cannot communicate clearly, such as young children. For example, behavioral tests require active participation from the patient, such as raising their hand when a sound is heard, or repeating words and sentences. Objective measures, for instance using electro-encephalography (EEG), could overcome the current challenges in hearing assessment and do not require active participation from the patient. For example, in Flanders, all newborns are screened with an objective test where a few sensors on the head detect brainwaves in response to sounds. However, objective tests only use simple sound stimuli, such as tones or clicks, which cannot be used to measure important high-level hearing outcomes, such as speech understanding. In other words, current objective tests are used to check if a person can hear a word, but they can't indicate if the person can understand the word. An obvious missing link in audiological practice is a diagnostic test that can measure high-level hearing outcomes such as speech understanding in an objective way. For this reason, CORGEE was developed. CORGEE uses a novel method of "neural speech tracking" to objectively measure speech intelligibility using EEG. In the current study, the efficacy and the clinical validity of the CORGEE software will be evaluated in young children with a hearing impairment.

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: NCT06400173 Recruiting - Dementia Clinical Trials

Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment

MoCA-HI
Start date: September 1, 2023
Phase:
Study type: Observational

The Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment that assesses several cognitive domains (attention and concentration, arithmetic and orientation, memory, etc.). The instructions as well as some test items of the MoCA are presented auditory (spoken). Consequently, performance on the MoCA may be co-dependent on hearing. Therefore, to rule out the possible negative influence of hearing loss on performance on the MoCA, a MoCA for individuals with hearing loss was recently developed. More specifically, the original MoCA was modified by providing the instructions audiovisually (spoken with visual support) as well as by replacing hearing-dependent items. Since replacing items may affect sensitivity and specificity, the MoCA for persons with hearing loss should be revalidated.

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.

NCT ID: NCT06375278 Not yet recruiting - Hearing Loss Clinical Trials

Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1. Is mild therapeutic hypothermia safe for use during cochlear implantation? 2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation? Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).

NCT ID: NCT06370351 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

AUDIOGENE
Start date: April 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

NCT ID: NCT06365775 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss

Start date: April 23, 2024
Phase:
Study type: Observational

The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are: - if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls - if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls - to find out which factor from multi-omics data relates to outcomes of SSNHL - to develop the best prognostics model based on the multi-omics data. Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.