Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Recruiting
CT.gov ID
NCT04923087
Collaborator
(none)
100
1
6
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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
Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?"

Outcome Measures

Primary Outcome Measures

  1. Perception of crunching despite presbycusis [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.

Secondary Outcome Measures

  1. Evaluation of plesure felt [a 10-min session]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de NICE Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04923087
Other Study ID Numbers:
  • 21odonto03
First Posted:
Jun 11, 2021
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2021