Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

NCT04923087 | Unknown FDA Device

• 1 other identifier: 21odonto03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Malnutrition; Anorexia; Presbycusis; Edentulism Nos

Outcome Measures

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.

  a 10-min session

Secondary Outcomes (1)

• Evaluation of plesure felt

  a 10-min session

Study Arms (1)

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

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

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

Patient hospitalized in geriatrics or EHPAD

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Frailty; Malnutrition; Anorexia; Presbycusis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Central Study Contacts

Valérie POUYSSEGUR, MD

CONTACT

+334 92 03 32 72; pouyssegur-rougier.v@chu-nice.fr

Claire LASSAUZAY, PhD

CONTACT

+334 92 03 32 72; lassauzay.c@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 11, 2021
• Study Start: June 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: November 30, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

FR (1)