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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia; Malnutrition; Frailty; Presbycusis; Edentulism Nos
• Intervention / Treatment: Device: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Valérie POUYSSEGUR, MD; Phone Number: +334 92 03 32 72; Email: pouyssegur-rougier.v@chu-nice.fr
• Study Contact Backup: Name: Claire LASSAUZAY, PhD; Phone Number: +334 92 03 32 72; Email: lassauzay.c@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Chu de Nice
    • Contact: CHU de NICE Odonthologie; Phone Number: +334 92 03 32 72; Email: pouyssegur-rougier.v@chu-nice.fr
    • Contact: Claire LASSAUZAY; Phone Number: +33492033272; Email: lassauzay.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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?"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	a 10-min session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of plesure felt	After eating each type of cookies, "Is it a pleasure?" question will be asked	a 10-min session

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms, Digestive; Nutrition Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Anorexia; Frailty; Malnutrition; Presbycusis
• Other Study ID Numbers: 21odonto03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes