- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04923087
Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021) (EDERE 2021)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Valérie POUYSSEGUR, MD
- Telefonnummer: +334 92 03 32 72
- E-mail: pouyssegur-rougier.v@chu-nice.fr
Undersøgelse Kontakt Backup
- Navn: Claire LASSAUZAY, PhD
- Telefonnummer: +334 92 03 32 72
- E-mail: lassauzay.c@chu-nice.fr
Studiesteder
-
-
-
Nice, Frankrig, 06000
- Rekruttering
- Chu De Nice
-
Kontakt:
- CHU de NICE Odonthologie
- Telefonnummer: +334 92 03 32 72
- E-mail: pouyssegur-rougier.v@chu-nice.fr
-
Kontakt:
- Claire LASSAUZAY
- Telefonnummer: +33492033272
- E-mail: lassauzay.c@chu-nice.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patient hospitalized in geriatrics or EHPAD
Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents
|
Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?"
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perception of crunching despite presbycusis
Tidsramme: 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.
|
a 10-min session
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of plesure felt
Tidsramme: a 10-min session
|
After eating each type of cookies, "Is it a pleasure?"
question will be asked
|
a 10-min session
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Patologiske processer
- Ernæringsforstyrrelser
- Tegn og symptomer, fordøjelsessystemet
- Otorhinolaryngologiske sygdomme
- Sensationsforstyrrelser
- Øresygdomme
- Høretab
- Hørelidelser
- Høretab, sensorineural
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Skrøbelighed
- Fejlernæring
- Anoreksi
- Presbycusis
Andre undersøgelses-id-numre
- 21odonto03
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .