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 pulsatile tinnitus (a rhythmic, heartbeat-like ringing or whooshing in your ear) that has lasted more than three months and significantly affects your daily life
• When a doctor presses on the jugular vein on the same side as your affected ear, the sound temporarily stops
• Imaging scans (MRI or CT) show a narrowing in a specific vein in your head called the lateral sinus
• Other causes of your pulsatile tinnitus have been ruled out through MRI and CT scans
• The narrowing is located in the main or equally important vein on that side of your head
• Pressure measurements taken during a procedure under general anaesthetic show a specific pressure difference across the narrowing (confirm with trial site for exact thresholds)
• You are actively seeking treatment for your pulsatile tinnitus
• You are willing to receive a specific medical device called the SiREX® Stent as part of the treatment
• You are able and willing to provide written consent to participate

Who may not be able to join:

• Your tinnitus is not pulsatile, or your pulsatile tinnitus is not caused by a narrowing in the lateral sinus vein
• The pressure difference across the narrowing in your vein does not meet the required minimum level (confirm with trial site)
• The size or shape of your vein is not suitable for the stent device being used
• Your blood vessels are too twisted or too narrow for the procedure to be safely performed
• You are unable to take blood-thinning or anti-clotting medications, or you did not receive these medications before the procedure
• You have had a recent bleed around the brain (subarachnoid haemorrhage)
• You currently have an active bacterial infection
• You have a known allergy or sensitivity to nickel-titanium (the material the stent is made from)
• You are currently pregnant or breastfeeding
• You are already taking part in another clinical trial
• You have experienced a life-threatening event in the last 6 months
• Your life expectancy is less than 12 months
• You have a serious ongoing condition such as cancer, dementia, or alcohol or drug dependency that could make it difficult to attend follow-up appointments

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