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Deafness clinical trials

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NCT ID: NCT04159428 Completed - Hearing Loss Clinical Trials

Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More

VF DEPIST 60
Start date: November 7, 2019
Phase:
Study type: Observational

Nowadays in France, there is no organized screening of the hearing loss in the elderly; however, it is a very common disease and simples tests to perform to detect it exist. Lots of studies use surveys to identify deaf people; but physicians often consider them too sensitive and less specific because lots of people were classified into " deaf " people meanwhile they have a subnormal tonal audiogram. Now, it's known that it corresponds to the "Hidden Hearing Loss" concept: it's defined as an auditive disturbance in a noisy ambiance in people with a normal tonal audiometry; corresponding to infraclinical cochlear lesions. These lesions, if detected early, can be prevented to avoid an audition degradation in time. The aim of the study is to determinate the values of sensitivity and specificity of the HHIE-S survey translated into French, so it could be used as a screening method of hearing loss in the elderly and as a prevention of cochlear damages.

NCT ID: NCT04155138 Not yet recruiting - Cochlear Implant Clinical Trials

Recipients With Limited Bimodal Benefit: HA or CROS

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.

NCT ID: NCT04152551 Recruiting - Clinical trials for Osteogenesis Imperfecta

Effects of Bisphosphonates on OI-Related Hearing Loss

Start date: November 2, 2019
Phase: Phase 4
Study type: Interventional

Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to OI-related hearing loss. As many individuals with OI-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both OI type I and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss. The investigators will enroll 50 individuals diagnosed with type I OI and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. The investigators will enroll 25 children (6-17 years of age) diagnosed with OI who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. The investigators will also observe 25 children (6-17 years of age) diagnosed with OI who are NOT currently receiving bisphosphonate treatment. The study duration is 63 months (approximately 5 years). Enrollment is anticipated to begin in November 2019.

NCT ID: NCT04145661 Completed - Clinical trials for Cochlear Hearing Loss

Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions.

Start date: November 20, 2019
Phase: N/A
Study type: Interventional

The investigators are interested in an additional hearing aid feature called non-linear frequency compression (NLFC). This aims to improve audibility of high frequency sounds by converting them into lower frequencies and has been shown to benefit those with moderate-severe sensorineural hearing loss (SNHL). Cochlear dead regions (DRs) are areas of the inner hearing organ (the cochlea) where there is little or no function and are commonly found in regions responsible for detecting high pitched (frequency) sounds. Not all people with hearing loss have DRs. The investigators would like to determine whether based on the presence or absence of DRs, patients with moderate-severe SNHL perform better or prefer their hearing aids programmed conventionally, or with NLFC activated. To do this, two participant groups will be created based on findings from the threshold equalising noise (TEN) test which identifies cochlear DRs. Two participant groups will be created; one group with DRs and one group without DRs. All participants will receive two hearing aids and will wear these programmed conventionally for ~six weeks and with NLFC activated for ~six weeks in a counterbalanced manner. Following each condition, participants will complete a questionnaire and various speech tests will be performed. This involves participants repeating sentences, words or speech sounds they hear from a speaker in quiet and in the presence of background noise. Individuals' scores will be calculated for each test and their performance when NLFC was activated and deactivated will be compared. This will be analysed alongside the questionnaire data to compare the 'DR' and 'no DR' group in both conditions. Findings may help to determine whether NLFC should be activated for all moderate-severe SNHL patients, or just those with DRs, helping clinicians to optimise hearing aid settings for patients.

NCT ID: NCT04132882 Available - Clinical trials for Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Start date: n/a
Phase:
Study type: Expanded Access

This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma. Approximately 10 patients will be treated as part of this program as specified below: Sodium Thiosulfate vials i.v. 80 mg/mL. This Compassionate Use Program for STS will consist of 2 phases: Screening: Patients will only be able to participate in this CUP if they meet the eligibility criteria. Treatment: Any clinical assessments, physical examinations, and dosage changes will be determined by the treating physician as per local standard medical practice. All serious adverse events (SAEs) will be reported. All related non-serious adverse events (AEs) will be reported where "related" means any event where a causal relationship between STS and the event is at least, a reasonable possibility. All non-serious AEs leading to dose modification or discontinuation will be reported. Pregnancies, outcomes of pregnancies, and exposure through breastfeeding will also be reported.

NCT ID: NCT04129983 Not yet recruiting - Clinical trials for Hearing Loss, Sudden

Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation

Start date: June 2020
Phase: N/A
Study type: Interventional

To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.

NCT ID: NCT04129775 Completed - Clinical trials for Sensorineural Hearing Loss

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Start date: October 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.

NCT ID: NCT04129697 Not yet recruiting - Clinical trials for Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid

Intratympanic Steroids for Sudden Hearing Loss

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.

NCT ID: NCT04120116 Completed - Clinical trials for Sensorineural Hearing Loss

FX-322 in Adults With Stable Sensorineural Hearing Loss

Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

NCT ID: NCT04108598 Recruiting - Clinical trials for Sensorineural Hearing Loss

The SeaSHeL National Prospective Cohort Study

SeaSHeL
Start date: October 7, 2019
Phase:
Study type: Observational

Each year, approximately 15,000 people in the United Kingdom experience sudden loss of hearing that is sensorineural in nature. In the majority of cases, the cause is unknown despite investigation, and these cases are termed idiopathic 'sudden onset sensorineural hearing loss' (SSNHL). Treatment options for idiopathic SSNHL mainly include steroid treatments, with considerable limitations in their effectiveness and evidence base. There are a number of new treatments being developed for idiopathic SSNHL based upon recent discoveries in underlying molecular mechanisms. These treatments require rigorous testing in clinical trials before they can become available for clinical use. To allow for such trials to be run effectively, there is an urgent need for information on patient numbers, geographical distribution, demographics, patient and treatment pathways, as well as outcomes. This study proposes to collect these data through an ENT trainee and Audiologist led nationwide prospective cohort study of adult patients presenting with SSNHL within the National Health Services (NHS). The study will take place at 97 NHS sites across England with Ear, Nose, and Throat (ENT) and Audiology services. Data once collected will be analysed to: 1. Establish the patient pathway for patients presenting with SSNHL in the NHS 2. Develop a tool that will help predict recovery for patients with idiopathic SSNHL. 3. Establish the impact of idiopathic SSNHL on people's quality of life.