{"type":"trials","record":{"id":42381,"source_id":"clinicaltrials-gov","external_id":"NCT04360109","title":"Study of the Association Between Presbycusis With the Incidence of Frailty","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.","overall_status":"Unknown","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Universidad Europea de Madrid","enrollment":300,"countries":["Spain"],"start_date":"2020-11-02","completion_date":"2022-11-01","last_update_date":"2021-10-22","source_url":"https://clinicaltrials.gov/study/NCT04360109","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:34.048307+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 99 Years","comparator":null,"organization":"Universidad Europea de Madrid","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Auditory function — 6 months","Frailty — 6 months","Determination of total polyphenols in urine — measured twice in each volunteer, at the beginning and end of the study p…","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)"],"design_description":null,"source_has_results":false},"controlled_terms":["Presbycusis","Frailty Syndrome","Oxidative Stress"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: presbycusis.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct04360109","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-11-02 to 2022-11-01","comparator":null,"confidence":"structured-source","population":"ALL · 60 Years to 99 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:04.666Z","intervention":[],"participants":300,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Auditory function — 6 months","Frailty — 6 months","Determination of total polyphenols in urine — measured twice in each volunteer, at the beginning and end of the study p…","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)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"hearing-aging","is_published":true,"match_reasons":["Title contains controlled term: presbycusis.","Abstract contains controlled term: presbycusis.","Source terminology contains: presbycusis.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Hearing ageing","slug":"hearing-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42381","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}