Study of the Association Between Presbycusis With the Incidence of Frailty

• Conditions: Oxidative Stress; Presbycusis; Frailty Syndrome

• Registration Number: NCT04360109
• Lead Sponsor: Universidad Europea de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-11-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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

Name	Time	Method
Microbiota	It will be performed at the beginning and at end of the study period (6 months)	Stool microbiota analysis
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.
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

Trial Locations

Locations (1)

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain