Ongoing Clinical Trials for Tinnitus
Two clinical trials are currently investigating new treatment approaches for tinnitus. These studies explore whether targeted injections of specific medications can help reduce the ringing or buzzing sounds that people with tinnitus experience. One trial focuses on patients who also have Menière’s disease, while the other examines patients with teeth grinding or jaw muscle pain. Both studies are being conducted in Europe and aim to improve quality of life for those affected by these conditions.
Clinical trial locations
- Netherlands
- Norway
Study on Meniere’s Disease: Comparing Methylprednisolone and Placebo for Patients with Unilateral Meniere’s Disease
This trial is being conducted in the Netherlands and focuses on patients who have both Menière’s disease and tinnitus. Menière’s disease is a disorder of the inner ear that causes episodes of severe dizziness (vertigo), hearing loss, and ringing in the ears. The study tests whether injections of methylprednisolone, a corticosteroid medication that reduces inflammation, can help reduce the frequency of vertigo attacks when injected directly into the ear.
Who can participate: The trial is open to adults over 18 years old who have been diagnosed with unilateral Menière’s disease, meaning the condition affects only one ear. Participants must have experienced at least 4 vertigo attacks in the past 6 months. Both men and women can join the study.
Who cannot participate: People who do not have unilateral Menière’s disease or who have the condition affecting both ears cannot join. Those participating in other clinical trials, individuals with allergies to the study medication, or people who have had recent surgery that might affect the study are excluded. Vulnerable populations such as pregnant women or those unable to provide informed consent also cannot participate.
What the trial aims to do: The main goal is to determine whether methylprednisolone injections are more effective than a placebo (inactive treatment) in reducing vertigo attacks over one year. The study will also monitor participants’ quality of life, including improvements in dizziness and tinnitus symptoms. Researchers will track how often additional treatments are needed and assess any changes in hearing and overall well-being.
The investigational drug: Methylprednisolone is delivered through intratympanic injection, which means it is injected directly into the middle ear. This method allows the medication to target the affected area more effectively. By reducing inflammation in the inner ear, the treatment may help decrease the frequency of vertigo episodes and associated symptoms like tinnitus.
Study on Botulinum Toxin A for Tinnitus in Patients with Bruxism or Jaw Muscle Pain
This trial is taking place in Norway and focuses on people who experience tinnitus alongside either bruxism (teeth grinding or clenching) or jaw muscle myalgia (pain in the jaw muscles). The study investigates whether injections of Botulinum toxin type A, commonly known as BOTOX, can help reduce tinnitus symptoms by relaxing the jaw muscles.
Who can participate: Adults aged 18 or older who have experienced tinnitus in one or both ears for more than three months can join. Participants must have severe bruxism or jaw muscle pain that has not responded well to other treatments. They need to have a Tinnitus Handicap Inventory score greater than 40, which indicates significant impact on daily life, and a pain score of 1 or higher for headaches or jaw pain. Normal hearing as assessed by audiometry is required. Participants must be able to understand and complete forms in Norwegian, and women of childbearing potential must use effective contraception.
Who cannot participate: People outside the 18-65 age range, those without tinnitus, and those without bruxism or jaw muscle pain cannot join. Individuals who are part of vulnerable populations or unable to provide informed consent are also excluded.
What the trial aims to do: The study will compare the effects of Botulinum toxin A injections to a placebo to see if the treatment can improve tinnitus symptoms, reduce teeth grinding, and alleviate jaw muscle pain. The primary measure of success is the change in Tinnitus Handicap Inventory score from the start of the trial to week 18. Secondary assessments include changes in headache intensity, jaw muscle pain levels, and overall quality of life. The trial uses a triple-blind design, meaning neither participants, healthcare providers, nor researchers know who receives the active treatment or placebo.
The investigational drug: Botulinum toxin A works by blocking nerve signals that cause muscle contractions, leading to muscle relaxation. In this trial, it is injected into the jaw muscles. The hypothesis is that by relaxing these muscles, the medication might help reduce tinnitus symptoms in patients whose condition is linked to jaw muscle tension or teeth grinding.
Summary
These two clinical trials represent different approaches to managing tinnitus based on its underlying causes. The Netherlands trial addresses tinnitus as part of Menière’s disease, focusing on reducing inflammation in the inner ear. The Norway trial takes a different approach, targeting muscle-related tinnitus associated with jaw tension and teeth grinding. Both studies use injectable medications delivered directly to the affected area, though they target different parts of the body and use different types of drugs. Notably, both trials are being conducted in Northern European countries and both compare their investigational treatments against placebo to ensure rigorous evaluation of effectiveness. These studies may provide valuable insights into personalized treatment approaches based on the specific characteristics and causes of tinnitus in different patient groups.
