The Brain&Senses Study

NCT06991816 | Active Not Recruiting

• 1 other identifier: NAFA2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Parkinson

Keywords

Cognitive Decline; Smell Loss; Vertigo/ Dizziness; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Impact of hearing loss, vertigo and smell loss on cognition

  All these measures are numeric. Vertigo will be yes (1) or no (0), same for hearing loss and smell loss

  5 years

Other Outcomes (3)

• Hearing Loss

  each year for 5 years

• Smell loss

  each year for 5 years

• Vertigo

  each year for 5 years

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by mild cognitive impairment (MCI), Alzheimer Disease in Early stage, Parkison Disease in early stage

You may qualify if:

• 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.

You may not qualify if:

• 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")

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Ospedali Riuniti Marche Nord, Fano-Pesaro Hospital: collaborator

Study Sites (1)

Vanvitelli ENT department

Naples, Campania, 80138, Italy

Location

Related Publications (12)

• Myrstad C, Engdahl BL, Costafreda SG, Krokstad S, Lin F, Livingston G, Strand BH, Ohre B, Selbaek G. Hearing impairment and risk of dementia in The HUNT Study (HUNT4 70+): a Norwegian cohort study. EClinicalMedicine. 2023 Dec 4;66:102319. doi: 10.1016/j.eclinm.2023.102319. eCollection 2023 Dec.

  PMID: 38192588 BACKGROUND

• O'Malley PG. Evolving insights about the impact of sensory deficits in the elderly: comment on "The prevalence of concurrent hearing and vision impairment in the United states" and "Hearing loss and cognitive decline in older adults". JAMA Intern Med. 2013 Feb 25;173(4):299. doi: 10.1001/jamainternmed.2013.3760. No abstract available.

  PMID: 23338615 RESULT

• Rong H, Lai X, Jing R, Wang X, Fang H, Mahmoudi E. Association of Sensory Impairments With Cognitive Decline and Depression Among Older Adults in China. JAMA Netw Open. 2020 Sep 1;3(9):e2014186. doi: 10.1001/jamanetworkopen.2020.14186.

  PMID: 32990739 RESULT

• Mahmoudi E. Hearing, Vision, or Dual Sensory Impairment and Dementia Risk. JAMA Netw Open. 2021 Mar 1;4(3):e211846. doi: 10.1001/jamanetworkopen.2021.1846. No abstract available.

  PMID: 33739427 RESULT

• Liljas AEM, Jones A, Cadar D, Steptoe A, Lassale C. Association of Multisensory Impairment With Quality of Life and Depression in English Older Adults. JAMA Otolaryngol Head Neck Surg. 2020 Mar 1;146(3):278-285. doi: 10.1001/jamaoto.2019.4470.

  PMID: 32027340 RESULT

• Stickel AM, Mendoza A, Tarraf W, Kuwayama S, Kaur S, Morlett Paredes A, Daviglus ML, Testai FD, Zeng D, Isasi CR, Baiduc RR, Dinces E, Lee DJ, Gonzalez HM. Hearing Loss and Associated 7-Year Cognitive Outcomes Among Hispanic and Latino Adults. JAMA Otolaryngol Head Neck Surg. 2024 May 1;150(5):385-392. doi: 10.1001/jamaoto.2024.0184.

  PMID: 38512278 RESULT

• An YY, Lee ES, Lee SA, Choi JH, Park JM, Lee TK, Kim H, Lee JD. Association of Hearing Loss With Anatomical and Functional Connectivity in Patients With Mild Cognitive Impairment. JAMA Otolaryngol Head Neck Surg. 2023 Jul 1;149(7):571-578. doi: 10.1001/jamaoto.2023.0824.

  PMID: 37166823 RESULT

• Lee EY, Eslinger PJ, Du G, Kong L, Lewis MM, Huang X. Olfactory-related cortical atrophy is associated with olfactory dysfunction in Parkinson's disease. Mov Disord. 2014 Aug;29(9):1205-8. doi: 10.1002/mds.25829. Epub 2014 Jan 30.

  PMID: 24482154 RESULT

• Kollndorfer K, Jakab A, Mueller CA, Trattnig S, Schopf V. Effects of chronic peripheral olfactory loss on functional brain networks. Neuroscience. 2015 Dec 3;310:589-99. doi: 10.1016/j.neuroscience.2015.09.045. Epub 2015 Sep 28.

  PMID: 26415766 RESULT

• Lin FR, Ferrucci L. Hearing loss and falls among older adults in the United States. Arch Intern Med. 2012 Feb 27;172(4):369-71. doi: 10.1001/archinternmed.2011.728. No abstract available.

  PMID: 22371929 RESULT

• Vohra V, Simonsick EM, Kamath V, Bandeen-Roche K, Agrawal Y, Rowan NR. Physical Function Trajectories and Mortality in Older Adults With Multisensory Impairment. JAMA Otolaryngol Head Neck Surg. 2024 Mar 1;150(3):217-225. doi: 10.1001/jamaoto.2023.4378.

  PMID: 38236596 RESULT

• Di Stadio A, Ralli M, Kaski D. Multisensory Rehabilitation in Older Adults to Improve Longevity and Wellness. JAMA Otolaryngol Head Neck Surg. 2024 Aug 1;150(8):748-749. doi: 10.1001/jamaoto.2024.1695. No abstract available.

  PMID: 38935395 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Anosmia; Hearing Loss

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

IT (1)