The Brain&Senses Study (NCT06991816) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Brain&Senses Study
Italy100 participantsStarted 2025-08-01
Plain-language summary
The aim of this longitudinal observational study is to evaluate the impact of sensory deficits (smell, hearing and balance on cognitive decline and quality of life in the medium term (5 years)) on a population of patients over 55.
Patients will be evaluated by a neurologist, a neuropsychologist and an otolaryngologist who will perform olfactory, auditory and vestibular tests.
The acquired data will then be analyzed with multivariate analysis to understand the effect of multisensory deficit on both cognition and quality of life with a particular focus on depression.
The primary objective will be the evaluation of multiple deficits on cognition, the secondary will be aimed at understanding whether one sensory deficit more than another, e.g. smell versus hearing, will have a greater impact on the patient's conditions.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients between 60 and 85 years of age
* in general good health
* the absence of known severe psychiatric disorders
* available to be included in the study and
* to follow the 5-year follow-up.
Exclusion Criteria:
* Obstructive nasal problems
* Previous endoscopic nose + paranasal sinus surgery
* Chronic use of cortisone spray and/or systemic
* Subjects with previous stroke and outcomes
* Subjects with history of stroke in the last 3 years without outcomes
* Head trauma in the last 24 months
* Previous ear surgery
* Patients who have been exposed to chemical agents without protection for work, e.g. carpenters
* previous Covid with outcomes (olfactory, vestibular, auditory and cognitive "brain fog")
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of hearing loss, vertigo and smell loss on cognition