{"type":"trials","record":{"id":28345,"source_id":"clinicaltrials-gov","external_id":"NCT04923087","title":"Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)","brief_summary":"Background. Decreased taste and smell contribute to loss of appetite (anorexia), and the resulting protein-energy malnutrition increases the frailty of the elderly. The risk of falls, disability, infections and depression often requires them to be institutionalized. Elderly, undernourished and toothless patients often complain about the monotony of a soft, mixed-texture diet. In a previous study, some participants highlighted the pleasure of crunching cookies that have a solid texture that can be eaten in any dental condition. However, the age-related decrease in hearing (presbyacusis) is frequent and progressive from the age of 60. The hypothesis of this work is that older patients may perceive a crunchy food crunching in their mouth, despite presbycusis. If the hypothesis is verified, this would make geriatric caregivers aware of the possibility of diversifying the texture of food, in order to stimulate the pleasure of eating and increase the dietary intake in this population of patients who are often undernourished, dysphagic, edentulous and hearing impaired. The originality of this study is to share the expertise of geriatricians and specialists in mastication/swallowing (dental surgeon, speech-language pathologist), hearing (ENT doctor, hearing care professional) and nutrition (dietician). Type of study. Type of study MR-004 \"Research not involving the human person\". Protocol. Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements: a soft filled cookie (Nutra Cake™, Délical, France) and a crunchy cookie of the Breton type (Protibis™, Solidages, France). Blind study impossible: each subject will eat a cookie then the other in a random order and will be his own control. The tests will be performed without the possible hearing aids, but with or without the dentures according to the patient's preference. Indeed, some patients have dental prostheses that are no longer suitable for chewing, and that they wear only for aesthetics. Objective. Validate the evaluation criteria \"Do you hear the biscuit crunch?\" and \"Is it a pleasure?\" If so, encourage diversification with crunchy foods with a suitable texture, as well as dental and prosthetic rehabilitation of dependent elderly people.","overall_status":"Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Centre Hospitalier Universitaire de Nice","enrollment":100,"countries":["France"],"start_date":"2021-06-01","completion_date":"2027-06-25","last_update_date":"2026-06-29","source_url":"https://clinicaltrials.gov/study/NCT04923087","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.50034+00:00","last_seen_at":"2026-09-25T06:25:08.953+00:00","metadata":{"sex":"ALL","acronym":"EDERE 2021","age_range":"65 Years","comparator":null,"organization":"Centre Hospitalier Universitaire de Nice","interventions":["Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Perception of crunching despite presbycusis — a 10-min session","Evaluation of plesure felt — a 10-min session"],"design_description":null,"source_has_results":false},"controlled_terms":["Frailty","Malnutrition","Anorexia","Presbycusis","Edentulism Nos","Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: presbycusis.","quality_checked_at":"2026-09-25T06:25:14.10514+00:00","duplicate_cluster_key":"id:nct04923087","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-06-01 to 2027-06-25","comparator":null,"confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:25:08.966Z","intervention":["Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements"],"participants":100,"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":["Perception of crunching despite presbycusis — a 10-min session","Evaluation of plesure felt — a 10-min session"],"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":["Abstract contains controlled term: presbycusis.","Source terminology contains: presbycusis.","Abstract supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/28345","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}