Phase 2 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:

• People who are between 45 and 65 years old at the time of their first screening visit.
• People who are willing and able to give written consent and follow the study requirements.
• People whose hearing test results show only mild or no hearing loss at standard sound frequencies, with both ears performing similarly, no significant difference between air and bone sound conduction, and normal middle-ear function on both sides (confirm with trial site for exact measurements).
• People who show no signs of cognitive difficulty on a standard thinking and memory screening test called the Montreal Cognitive Assessment (MoCA).
• People whose inner ear function test (called a DPOAE) shows no more than mild hearing loss at standard sound frequencies (confirm with trial site).
• People who perform poorly on a specific test of hearing in noisy conditions at a 15-degree sound angle, meaning their score falls well below what is typical for people with normal hearing (confirm with trial site for exact scoring threshold).

Who may not be able to join:

• People who do not meet all of the inclusion criteria listed above.
• People with a known allergy or sensitivity to clemastine fumarate or similar antihistamine medicines.
• People who are pregnant or breastfeeding, as confirmed by a urine pregnancy test.
• People with lower respiratory conditions such as asthma, emphysema, or chronic bronchitis.
• People with glaucoma or raised pressure inside the eye.
• People with certain stomach or digestive conditions, including stenosing peptic ulcers or a blockage between the stomach and small intestine (confirm with trial site).
• People who have difficulty urinating due to a significantly enlarged prostate gland (note: mild prostate enlargement is not an automatic exclusion, but the trial site will need to discuss the possible side effects with those individuals).
• People with significant heart or blood vessel disease, long-term high blood pressure, or persistently low blood pressure.
• People with an overactive thyroid gland.
• People whose alcohol consumption averages three or more drinks per day (for women) or four or more drinks per day (for men), or who have previously been diagnosed with alcohol use disorder.
• People with a history of seizures.
• People who show signs of suicidal thoughts or behaviour based on a standard clinical assessment scale.
• People with significant or uncontrolled conditions affecting the liver, kidneys, blood, digestive system, nervous system, or mental health, as identified through physical examination, heart tracing (ECG), and blood tests — including specific blood count and metabolic panel results that fall outside acceptable ranges (confirm with trial site for exact thresholds).
• People currently taking monoamine oxidase inhibitor (MAOI) medications.
• People currently taking medications that slow down the central nervous system, such as sedatives, tranquilisers, or sleeping tablets.
• People with a significant history of ear disorders, such as repeated ear infections or Ménière's disease.
• People with a significant history of neurological conditions, or current neurodegenerative diseases such as multiple sclerosis.
• People with a history of traumatic brain injury or closed head injury.
• People for whom English is not their first language, as this is known to affect scores on the speech recognition tests used in this trial.
• People with any other condition that, in the opinion of the trial investigators, could affect the safety of the participant or the reliability of the study results.

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