Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older
• You have a confirmed diagnosis of Idiopathic Intracranial Hypertension (IIH) — a condition where pressure in the skull is too high — that was made using a specific set of medical criteria, and you have been on standard medical treatment including a medicine called acetazolamide for more than 1 year
• Your intracranial (skull) pressure has been measured and found to be above a certain high level
• A brain scan (MRI) has shown a narrowing in specific veins inside your skull called the transverse venous sinuses
• Your MRI results are otherwise normal, apart from findings related to IIH or the vein narrowing mentioned above
• You have been given information about the trial, and you have signed and dated a consent form agreeing to take part
• You are able to attend all required appointments and follow all trial procedures
• You are covered by public health insurance

Who may not be able to join:

• You have taken a medicine called topiramate in the past month
• You have a known allergy to contrast dye (used in scans), nickel, or titanium
• You have taken certain medicines (such as lithium, vitamin A, tetracyclines, or similar drugs) within 2 months of your IIH diagnosis that are known to raise pressure in the skull
• You have a history of a blood clot in a brain vein (intracranial venous thrombosis) or a brain tumour
• You have experienced a rapid and severe loss of vision in your worse eye due to IIH, along with significant damage to your visual field
• You have damage (wasting) of your optic nerve (the nerve connecting your eye to your brain)
• You have a condition called amblyopia (sometimes called "lazy eye")
• You have a high level of short- or long-sightedness or astigmatism alongside certain other eye conditions such as glaucoma or other causes of vision loss (confirm with trial site)
• You are pregnant, or a pregnancy test comes back positive
• You have a serious or life-threatening illness that would make it unlikely you would benefit from the procedure or be able to complete the trial
• There is evidence of bleeding inside your skull (such as a brain haemorrhage)
• Your life expectancy is less than 6 months
• You have kidney failure or poor kidney function, unless you are already on dialysis
• You have previously had a stent placed inside a vein in your skull
• You have previously had gastric bypass surgery
• You have a medical reason why you cannot have a general anaesthetic
• You cannot take blood-thinning or anti-clotting medicines such as aspirin, clopidogrel, or similar drugs
• You have a history of chronic lung disease or another serious breathing condition
• You have a history of deep vein thrombosis (a blood clot, usually in the leg) or a pulmonary embolism (a blood clot in the lungs)
• You have a history of an irregular heart rhythm (atrial fibrillation) or other conditions that increase your risk of stroke
• You have certain blood vessel abnormalities in the brain, such as aneurysms, arteriovenous malformations, or significant narrowing of other blood vessels in or around the brain
• The shape or structure of your veins in the skull makes it unsafe to carry out the procedure (confirm with trial site)
• You work for or are otherwise dependent on the organisation running this trial
• You have taken part in another clinical trial or received an unapproved medicine within the last 4 weeks
• You are in a legally protected category under French law, such as being under legal guardianship, being a prisoner, or being pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.