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Sudden 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: NCT05086276 Completed - Clinical trials for Hearing Loss, Sensorineural

FX-322 in Adults With Acquired Sensorineural Hearing Loss

Start date: October 12, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

NCT ID: NCT04902963 Completed - Clinical trials for Eustachian Tube Dysfunction

What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

Start date: March 15, 2011
Phase: N/A
Study type: Interventional

Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

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: 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: NCT04449848 Not yet recruiting - Sudden Hearing Loss Clinical Trials

The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

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

During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.

NCT ID: NCT04384640 Not yet recruiting - Sudden Hearing Loss Clinical Trials

The Effect of Patient's Position After Intra-tympanic Injection

Start date: July 1, 2020
Phase:
Study type: Observational

The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.

NCT ID: NCT04192656 Recruiting - Clinical trials for Obstructive Sleep Apnea

The Effect of PAP on ISSHL Comorbided With OSA

Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.

NCT ID: NCT03974867 Not yet recruiting - Sudden Hearing Loss Clinical Trials

Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

Start date: July 2019
Phase: N/A
Study type: Interventional

Idiopathic sudden sensorineural hearing loss (ISSNHL) is a complicated hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction like vertigo has been considered as a risk factor of profound hearing loss and poor prognosis in ISSNHL. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to evaluate the recovery pattern and possible process of vestibular system in ISSNHL with vestibular dysfunction, and to compare the efficacy of oral or intratympanic glucocorticoids in these participants. A randomized, outcome assessor- and statistical analyst-blinded, controlled, clinical trial will be carried out. 72 patients complaining of vestibular dysfunction appearing as vertigo, dizziness, imbalance or lateropulsion with ISSNHL will be recruited and randomized into two arms of oral or intratympanic glucocorticoids therapy in 1:1 allocation. The primary outcomes will be subjective feelings evaluated by duration of vestibular dysfunction symptoms, dizziness-related handicap, visual analogue scale for vertigo, and objective vestibular function tests results assessed by sensory organization test, caloric test, video head impulse test and vestibular evoked myogenic potentials. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization.

NCT ID: NCT03951584 Completed - Vestibular Disorder Clinical Trials

Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Start date: May 15, 2019
Phase:
Study type: Observational

Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.