FrailtyEDERE 2021NCT04923087
Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)
An observational study of Frailty and Malnutrition, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Malnutrition, Anorexia
- What is being tested?
- Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 25 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Subjects 65 years of age or older, hospitalized in geriatrics or living in a nursing home.
Who may be able to join
- Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents.
Who cannot join
- risk of false route when eating cookies, allergy to an ingredient in cookies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE
Nice, 06000
CHU de NICE Odonthologie, +334 92 03 32 72, pouyssegur-rougier.v@chu-nice.fr
Claire LASSAUZAY, +33492033272, lassauzay.c@chu-nice.fr
About this study
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
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.
- Conditions
- Frailty, Malnutrition, Anorexia, Presbycusis, Edentulism Nos
- Being tested
- Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements
- Medical subject headings
- Frailty, Malnutrition, Anorexia, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare the noise and pleasure of crunching between two hyperprotein nutritional supplementsDevice
Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?"
| Study group | Role | What they receive |
|---|---|---|
| Patient hospitalized in geriatrics or EHPAD | Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents Receives: Device: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: a 10-min session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Aug 2021
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923087
- Sponsor's protocol ID
- 21odonto03
- Acronym
- EDERE 2021
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04923087
- Acronym / sponsor ID
- EDERE 2021 / 21odonto03
- Conditions
- Frailty, Malnutrition, Anorexia, Presbycusis, Edentulism Nos
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient hospitalized in geriatrics or EHPAD | – | Device: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplementsSubjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Subjects 65 years of age or older, hospitalized in geriatrics or living in a nursing home.
Key inclusion criteria (1 listed)
- Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents.
Key exclusion criteria (1 listed)
- risk of false route when eating cookies, allergy to an ingredient in cookies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compare the noise and pleasure of crunching between two hyperprotein nutritional supplementsValidate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?" | Device | Patient hospitalized in geriatrics or EHPAD |
Primary outcome
Perception of crunching despite presbycusis
Time frame: a 10-min session
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.
1 secondary outcome
Evaluation of plesure felt
Time frame: a 10-min session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Malnutrition, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie POUYSSEGUR, MD (+334 92 03 32 72, pouyssegur-rougier.v@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of crunching despite presbycusis (time frame: a 10-min session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.