Ongoing Clinical Trials for Traumatic Deafness
Currently, there is one clinical trial investigating treatment options for traumatic deafness, specifically focusing on acute acoustic trauma caused by sudden exposure to loud noise. This trial is testing whether hyperbaric oxygen therapy can help restore hearing after noise-related injury and comparing two different treatment schedules to determine the most effective approach.
Clinical trial locations
- Netherlands
Study of Hyperbaric Oxygen Therapy Administered Once or Twice Daily for Patients with Acute Acoustic Trauma
This clinical trial is investigating whether hyperbaric oxygen therapy can help people who have experienced sudden hearing loss due to exposure to very loud noise. The study takes place in the Netherlands and focuses on finding the best treatment schedule for this condition.
What is being tested: The trial examines hyperbaric oxygen therapy, a treatment where patients breathe pure oxygen inside a special pressurized chamber. This oxygen-rich environment is designed to help repair damaged tissues in the inner ear and promote healing. The study compares two different treatment schedules: receiving the therapy twice daily for five days versus once daily for ten days.
Who can participate: To join this study, you must be at least 18 years old and have been diagnosed with acute acoustic trauma confirmed by a hearing test. It is essential that you visit an ear specialist between 24 and 72 hours after being exposed to the loud noise that caused your hearing damage. Your hearing loss must meet specific minimum levels, such as a loss of 30 decibels at one tested frequency, 25 decibels at two frequencies, or 20 decibels at three frequencies. Both men and women can participate.
Who cannot participate: This study cannot accept people under 18 years old or those who have any medical condition that would make hyperbaric oxygen therapy unsafe. You cannot participate if your hearing loss occurred more than 14 days before seeking treatment, if you have permanent hearing damage from previous conditions, or if you have untreated ear infections or active ear diseases. People who are claustrophobic may find the enclosed treatment chamber difficult, as the therapy requires staying inside it during sessions. Those with certain lung conditions, recent ear or head surgery, or who are currently in other clinical trials are also excluded. Additionally, you must be able to commit to attending either once-daily sessions for 10 days or twice-daily sessions for 5 days.
What happens during the trial: First, your hearing will be carefully evaluated through audiometry to confirm the diagnosis and measure the extent of your hearing loss. Once enrolled, you will be assigned to one of the two treatment schedules. During treatment, you will breathe pure oxygen in a pressurized chamber according to your assigned schedule. The chamber increases air pressure to three times higher than normal atmospheric pressure, which helps deliver more oxygen to damaged tissues in your inner ear. Each session typically lasts between 60 and 90 minutes. One month after completing your treatment course, you will have another hearing test to measure how much your hearing has improved.
Purpose of the study: The main goal is to determine whether one treatment schedule works better than the other in restoring hearing after acoustic trauma. By comparing the twice-daily five-day schedule with the once-daily ten-day schedule, researchers hope to identify the most effective approach to help patients recover their hearing after noise-related injury.
Summary
Currently, only one clinical trial is actively recruiting patients with traumatic deafness, specifically those who have experienced acute acoustic trauma from sudden loud noise exposure. This trial is located in the Netherlands and focuses exclusively on hyperbaric oxygen therapy as a potential treatment. The study takes a practical approach by comparing two different treatment schedules to help determine not just whether the therapy works, but also which schedule might be more convenient and effective for patients. The trial emphasizes early intervention, requiring patients to seek treatment within 24 to 72 hours after noise exposure, highlighting the importance of prompt medical attention for this type of hearing injury.
