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:

• Adults between 18 and 80 years old (male or female)
• People who are able to give their informed consent to take part in the study
• People who have severe or very serious pulsatile tinnitus (a rhythmic ringing or whooshing sound in the ears) that temporarily improves when pressure is applied to the jugular vein in the neck
• People who have a narrowing of more than 50% in a specific vein in the brain (the transverse cerebral venous sinus), confirmed by a specialised scan (CT, MRI, or catheter angiography), and where the vein is a suitable size for the device being studied
• People who have already tried at least one non-surgical treatment for their tinnitus without enough improvement
• People who are willing to attend all required check-ups and follow-up appointments at the treatment centre
• People with a life expectancy of more than 12 months

Who may not be able to join:

• People whose vein narrowing is caused by an underlying condition (such as a brain tumour) that could be treated by other established methods like surgery or embolisation
• People who have previously had a stent placed in the vein being targeted in this trial
• People who cannot take blood-thinning or clot-dissolving medications for medical reasons
• People whose vein size falls outside the required range for the device used in this trial (confirm with trial site)
• People with a history of severe allergic reactions to contrast dye used in scans, or to nickel
• People whose tinnitus does not have a rhythmic, pulse-like quality
• People currently diagnosed with papilledema (swelling of the optic nerve at the back of the eye)
• People who have an abnormal connection between arteries and veins near the brain (dural arteriovenous fistula or arteriovenous malformation)
• People with a history of untreated irregular heart rhythm (atrial fibrillation), uncontrolled high blood pressure, or other risk factors for stroke
• People with a history of blood clots in the deep veins or lungs (deep vein thrombosis or pulmonary embolism)
• People with a history of heart failure, an enlarged heart condition, or a heart condition present from birth
• People with narrowing, tearing, or bulging of an artery
• People whose tinnitus is caused by something other than a narrowing of the cerebral venous sinus
• People who currently have an active infection anywhere in the body
• People whose vein anatomy (such as clots, twisting, or unusual shape) would make it unsafe to place the device
• People who have a small pouch (diverticulum) on their venous sinus that the investigator believes needs a treatment other than stenting
• People with ear or hearing conditions that could interfere with assessing tinnitus, such as extreme sound sensitivity
• People with blood-clotting disorders (either excessive clotting or bleeding) that cannot be managed with medication
• People who have had a stroke within the past 6 months
• People with a low platelet count below 100,000 per microlitre of blood
• People currently taking part in another clinical research trial
• People with a weakened immune system
• Women who are pregnant or breastfeeding (women under 45 who could become pregnant will need to provide a negative pregnancy test result before joining)
• People with other health conditions that the investigator believes would make the procedure unsafe or ineffective
• People who are unable to understand or provide informed consent for any reason

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