Study of the Association Between Presbycusis With the Incidence of Frailty

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT04360109
Collaborator
(none)
300
1
24
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of the Association Between Presbycusis With the Incidence of Frailty. Intake of Polyphenols for the Prevention of Presbycusis: Effects on Frailty
    Actual Study Start Date :
    Nov 2, 2020
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Auditory function [6 months]

      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).

    2. Frailty [6 months]

      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.

    Secondary Outcome Measures

    1. Determination of total polyphenols in urine [measured twice in each volunteer, at the beginning and end of the study period (6 months)]

      24-hour urine samples using the method Folin -Ciocalteu.

    2. Blood analysis, [It will be performed at the beginning and at end of the study period (6 months)]

      routine biochemistry and determination of: carotenoids, vitamins E and D

    3. Microbiota [It will be performed at the beginning and at end of the study period (6 months)]

      Stool microbiota analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age
    Exclusion Criteria:
    • Disease of the hearing system

    • Serious illness (e.g. tumor)

    • Dementia

    • Total dependence

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de Getafe Getafe Madrid Spain 28905

    Sponsors and Collaborators

    • Universidad Europea de Madrid

    Investigators

    • Principal Investigator: Carolina S Rodríguez, Universidad Europea de Madrid

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carolina Sánchez Rodríguez, Principal Investigator, Universidad Europea de Madrid
    ClinicalTrials.gov Identifier:
    NCT04360109
    Other Study ID Numbers:
    • PI19/01524
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2021