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Deafness clinical trials

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NCT ID: NCT04629664 Completed - Clinical trials for Hearing Loss, Sensorineural

FX-322 in Adults With Severe Sensorineural Hearing Loss

Start date: November 2, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.

NCT ID: NCT04623112 Completed - Clinical trials for Severe-profound Hearing Impairment

Use of Frequency Compression in Severe-profound Hearing Loss Adults

FC
Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.

NCT ID: NCT04622059 Completed - Hearing Loss Clinical Trials

AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis

AUDIO
Start date: September 2016
Phase: N/A
Study type: Interventional

The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.

NCT ID: NCT04604548 Completed - Clinical trials for Mitochondrial Diseases

The KHENEREXT Study

Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202. In the KH176-203 study subjects will be receiving KH176 100 mg BID or KH176 50 mg bid in die (BID) (as determined by the investigator based on safety / tolerability considerations) for a year, thereby ensuring continued treatment with KH176 after study KH176-202. A final follow-up visit is scheduled 4 weeks after the intake of the last dose of study medication for patients not rolling over into the compassionate use program. Primary safety data and secondary efficacy (endpoint) data will be monitored and reviewed every three months by an independent Data Safety Monitoring Board (DSMB) to evaluate potential risks and benefits.

NCT ID: NCT04601909 Completed - Clinical trials for Hearing Loss, Sensorineural

FX-322 in Adults With Age-Related Sensorineural Hearing Loss

Start date: September 17, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with age-related sensorineural hearing loss.

NCT ID: NCT04575051 Completed - Clinical trials for Hearing Loss, Age-Related

Hearing for Communication and Resident Engagement

HearCARE
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Amplification is a well-established, evidence-based front-line treatment for those with impaired communication secondary to Age Related Hearing Loss (ARHL). ARHL is the most prevalent cause of communication impairment among older adults. The challenge in treating ARHL is identifying a care model that effectively promotes adherence to individualized-treatment recommendations allowing the end-user to self-manage hearing loss with appropriate support. This proposal compares the two most common models of care for ARHL provided to adults in assisted living/personal care communities. The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility. The Engage Model is a chronic care approach to support hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.

NCT ID: NCT04571333 Completed - Cochlear Implants Clinical Trials

Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.

TICI
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.

NCT ID: NCT04563884 Completed - Deafness Clinical Trials

Validity of the French Version of Deafness Questionnaires for Children and Adolescents

SSQ-PEACH
Start date: October 4, 2020
Phase:
Study type: Observational

The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone. Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population. Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations. The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group. The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.

NCT ID: NCT04559282 Completed - Hearing Loss Clinical Trials

Home Test of New Sound Processor

Start date: September 23, 2020
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.

NCT ID: NCT04505696 Completed - Clinical trials for Head and Neck Cancer

Providing Speech Therapy Awareness in Private Schools

Start date: August 5, 2020
Phase: N/A
Study type: Interventional

There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. This Quasi experimental study will be a means of reaching out to schools and directly create awareness regarding the field and its scope. Pre-assessment will be carried out and after which a 45 minutes presentation will be conducted face to face or through a webinar as per school directives. The results will be analysed quantitatively and pre-post assessment of the participants will be measured.