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Clinical Trials in Italy / NCT06991816
Active, not recruiting Observational

The Brain&Senses Study

NCT06991816 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Campania Luigi Vanvitelli
Phase
Observational
Started
2025-08-01
Last updated
2026-04-23

Condition(s) studied

Mild Cognitive ImpairmentAlzheimer DiseaseParkinson

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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")

Primary outcome measure(s)

  • Impact of hearing loss, vertigo and smell loss on cognition — 5 years
    All these measures are numeric. Vertigo will be yes (1) or no (0), same for hearing loss and smell loss

Trial sites (1)

FacilityCityRegionStatus
Vanvitelli ENT department Naples Campania

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06991816 on ClinicalTrials.gov ↗ ← All trials in Italy