Study of the Association Between Presbycusis With the Incidence of Frailty

NCT04360109 | Unknown

• 1 other identifier: PI19/01524
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the project is to establish the association between presbycusis and the incidence of frailty in humans in order to establish hearing loss with age as another index for the diagnosis of frailty; As well as studying the effect of exposure to polyphenols in the diet on presbycusis and frailty. Human study: volunteers between 60 and 99 years old, men and women during a period of 6 months, questions and answers, audiometries, study of fragility, analysis of antioxidants in blood, and samples of urine will be measured Total polyphenols and oxidant capacity.

Conditions

Presbycusis; Frailty Syndrome; Oxidative Stress

Outcome Measures

Primary Outcomes (2)

• Auditory function

  study by pure tone audiometry, calculating an average of the thresholds of hearing at 0.5, 1, 2 and 4 kilohertz classifying according to their hearing thresholds to the participants in: normal hearing ≤ 25decibel, slight hearing loss = 26-40 decibel; Y moderate-greater hearing loss\> 40 decibel (according to the World Health Organization).

  6 months

• Frailty

  Fragility will be determined at the beginning and at the end of the study period using the 5 Fried indexes: weakness, low speed, low physical activity, exhaustion and weight loss. Participants with 3 or more criteria are classified as fragile, with 1-2 criteria as pre-fragile, and those without any criteria are not considered fragile. Thus, individuals will be classified in the analyzes as non-fragile, pre-fragile and fragile.

  6 months

Secondary Outcomes (3)

• Determination of total polyphenols in urine

  measured twice in each volunteer, at the beginning and end of the study period (6 months)

• Blood analysis,

  It will be performed at the beginning and at end of the study period (6 months)

• Microbiota

  It will be performed at the beginning and at end of the study period (6 months)

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who meet the inclusion and exclusion criteria and who attend the ENT or geriatrics clinic

You may qualify if:

• Age

You may not qualify if:

• Disease of the hearing system
• Serious illness (e.g. tumor)
• Dementia
• Total dependence

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

MeSH Terms

Conditions

Presbycusis; Frailty

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Carolina S Rodríguez

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodríguez

CONTACT

91- 683 93 60; carolina.sanchez2@universidadeuropea.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: April 24, 2020
• Study Start: November 2, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

ES (1)