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RecruitingNCT04923087EDERE 2021Updated Jun 29, 2026

Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

An observational study in Frailty, Malnutrition and Anorexia, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Frailty
  • Malnutrition
  • Anorexia
  • Presbycusis
  • Edentulism Nos
03

In context

Frailty

1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.

This study's planned enrollment of 100 is below the median of 225 across 493 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects 65 years of age or older, hospitalized in geriatrics or living in a nursing home.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient hospitalized in geriatrics or EHPAD

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

    Device: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements

Interventions

  • DeviceCompare 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?"

06

What researchers measure

Primary outcomes

  1. Perception of crunching despite presbycusis

    Subjects will be invited to eat two types of protein-rich cookies : Protibis (Solidages, France) and Nautre Cake (Delical, France). "Do you hear the biscuit crunch?" question will be asked.

    Time frame: a 10-min session

Secondary outcomes

  1. Evaluation of plesure felt

    After eating each type of cookies, "Is it a pleasure?" question will be asked

    Time frame: a 10-min session

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04923087
Responsible party
Sponsor
First posted
Jun 11, 2021
Start date
Jun 1, 2021
Primary completion
Aug 31, 2021
Completion
Jun 25, 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Valérie POUYSSEGUR, MD
Contact
pouyssegur-rougier.v@chu-nice.fr
+334 92 03 32 72
Claire LASSAUZAY, PhD
Contact
lassauzay.c@chu-nice.fr
+334 92 03 32 72

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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