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Recruiting NCT04923087

Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

Observational Frailty Malnutrition Anorexia Presbycusis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements.
Who it may be relevant to
Registry conditions: Frailty, Malnutrition, Anorexia, Presbycusis. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Auditory Stimulation in Eating Pleasure : Multicentric Study With Biscuits With Crunchy Texture vs Soft Texture in 100 Seniors Affected or at Risk of Presbyacusis

Overview

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.

Interventions

  • Device Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements
    Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?"

Primary outcome measures

  • Perception of crunching despite presbycusis [Time frame: a 10-min session]
Secondary outcome measures (1)
  • Evaluation of plesure felt [Time frame: a 10-min session]

Eligibility criteria

Inclusion criteria

Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents.

Exclusion criteria

risk of false route when eating cookies, allergy to an ingredient in cookies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU de NICE — Nice

Identifiers

NCT: NCT04923087 · 21odonto03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗