Deafness neurosensory Trials in Disease

Study of Hyperbaric Oxygen Therapy Combined with Standard Treatment for Patients with Sudden Hearing Loss

This study is investigating whether adding hyperbaric oxygen therapy to standard treatment can improve outcomes for people with sudden hearing loss. The condition being studied is idiopathic sudden sensorineural hearing loss, which means hearing suddenly deteriorates without a known cause.

Main inclusion criteria:

• Adults between 18 and 80 years old
• Sudden hearing loss that started no more than 7 days ago
• Hearing test showing nerve-related hearing loss with at least 30 decibels loss in three consecutive frequencies
• Average hearing threshold of 50 decibels or more when tested at different sound frequencies
• The hearing loss has no known cause according to doctor's assessment

Main exclusion criteria:

• Under 18 years of age
• Medical conditions that make hyperbaric oxygen therapy unsafe
• Hearing loss with a known cause
• Hearing loss symptoms present for more than 14 days
• Chronic ear diseases or inability to equalize ear pressure
• Claustrophobia, untreated collapsed lung, or severe heart or lung diseases
• Pregnancy
• Previous hyperbaric oxygen therapy for hearing loss
• Participation in other clinical trials

Focus of the trial: The study aims to determine if adding hyperbaric oxygen therapy to standard care can improve hearing outcomes better than standard care alone. Participants will receive either standard treatment alone or standard treatment combined with hyperbaric oxygen therapy for up to 16 days. Hearing ability will be measured using various tests, with particular focus on hearing levels after three months of treatment.

Investigational treatments: The trial is testing hyperbaric oxygen therapy, where patients breathe pure oxygen in a pressurized chamber. This increases the amount of oxygen dissolved in the blood, potentially helping damaged inner ear tissues. All participants also receive standard care treatment, which typically includes oral steroids and other conventional medical treatments.

Study on ACOU085 to Prevent Hearing Loss in Testicular Cancer Patients Receiving Cisplatin

This trial focuses on preventing hearing loss in men with testicular cancer who need chemotherapy with cisplatin, a drug known to potentially damage hearing. The study is testing a protective medication called ACOU085.

Main inclusion criteria:

• Male adults between 18 and 45 years old
• Confirmed diagnosis of testicular cancer requiring cisplatin chemotherapy
• Planned treatment with at least 300 mg/m² of cisplatin over 3 cycles
• Normal ear examinations and normal hearing in both ears according to WHO standards (hearing levels between 0 to 19 decibels at certain frequencies)
• Normal distortion product oto-acoustic emissions test results
• Normal heart rate, blood pressure, ECG, and liver and kidney function
• Willingness to use two forms of birth control for 6 months after starting the study
• Ability to understand and speak German fluently

Main exclusion criteria:

• Not male
• Outside the specified age range
• Part of a vulnerable population requiring special protection

Focus of the trial: The study aims to determine whether ACOU085 can effectively protect hearing in patients undergoing cisplatin treatment. Participants will receive injections of either ACOU085 or placebo directly into their ears. Regular hearing tests will monitor any changes and compare effects between the treated ear and the ear that received placebo.

Investigational drug: ACOU085 is administered as a gel-like substance through transtympanic injection directly into the ear. It is designed to protect the inner ear from damage caused by cisplatin chemotherapy. The medication targets molecular pathways involved in hearing function and is classified as an otoprotective agent.

Study on the Effectiveness and Safety of AC102 Injection vs. Oral Prednisolone for Patients with Sudden Hearing Loss

This study compares two different treatments for idiopathic sudden sensorineural hearing loss: a single injection of AC102 into the middle ear versus oral steroid tablets. The goal is to evaluate which treatment is more effective and better tolerated.

Main inclusion criteria:

• Adults between 18 and 85 years old
• Sudden hearing loss in one ear that started between 24 to 120 hours before joining the study
• Hearing threshold of at least 65 decibels in the affected ear
• Hearing loss of at least 30 decibels compared to the unaffected ear
• Ability to attend all trial visits and participate in hearing tests
• Female participants of childbearing potential must have a negative pregnancy test and agree to reliable birth control
• Male participants with partners who could become pregnant must agree to use reliable birth control

Main exclusion criteria: The trial does not specify detailed exclusion criteria in the provided information.

Focus of the trial: The study monitors changes in hearing ability over approximately 28 days, with additional assessments up to 84 days. Participants receive either a single AC102 injection into the middle ear or oral Prednisolone tablets. Regular hearing tests measure improvements in hearing thresholds and speech recognition abilities.

Investigational treatments: AC102 is an investigational medication given as a single dose directly into the ear. The study compares it to oral steroids (Prednisolone), which are medications taken by mouth that help reduce inflammation and are commonly used to treat sudden hearing loss.

Study on the Effects of Intracochlear Triamcinolone Acetonide for Patients with Persistent Sudden Sensorineural Hearing Loss After Unsuccessful Conservative Treatment

This trial is testing a treatment for people with sudden hearing loss who have not improved with standard treatments like oral or ear injections of steroids. The treatment involves injecting triamcinolone acetonide directly into the cochlea, the part of the inner ear responsible for hearing.

Main inclusion criteria:

• Adults between 18 and 80 years old
• Sudden hearing loss within the last 21 days
• No recovery after trying standard treatments with steroids by mouth or through the ear
• Hearing loss of at least 30 decibels in three nearby sound frequencies
• Average hearing loss of at least 70 decibels in the frequencies of 0.5, 1, 2, and 4 kilohertz
• Agreement to participate by signing a consent form

Main exclusion criteria:

• Not having experienced sudden sensorineural hearing loss
• Not having tried and failed conservative therapy
• Not within the specified age range
• Being part of a vulnerable population such as children, pregnant women, or those unable to consent

Focus of the trial: The study evaluates how well intracochlear injection of triamcinolone acetonide improves hearing in patients who have not responded to other treatments. Participants receive either the medication or placebo injected directly into the cochlea. Hearing is monitored over 30 days using tests that measure the ability to hear different tones and understand speech.

Investigational drug: Triamcinolone acetonide is a corticosteroid that reduces inflammation and swelling in the inner ear. By applying it directly into the cochlea, the medication aims to target the affected area and potentially restore some hearing function. It is known by the brand name Volon® A 40 mg and is classified as a glucocorticoid.