Age-related Hearing Loss and Lexical Disorders

Alzheimer Disease Clinical Trial

— LOOP  

Official title:

Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638323
• Other study ID #: 2018/P08/256
• Status: Completed
• Start date: August 27, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2019
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In France, Alzheimer's disease accounts for 70 to 80% of the causes of neurocognitive disorders, i.e. 600,000 to 800,000 patients. It is a neurodegenerative pathology that causes evolutionary cognitive dysfunction, mainly affecting memory functions. The inability to name familiar objects (lack of the word) is one of the most commonly noted symptoms at an early stage of the disease.

Presbyacusis, or age-related hearing loss, is the most common sensory deficit in the elderly which is manifested socially by a progressive discomfort of verbal communication. Presbyacusis remains underdiagnosed and undertreated: 2/3 of the patients are not using hearing aid.

In recent years, a link between neurocognitive disorders and hearing loss has been shown by investigating general cognition. In this study, the investigators are investigating lexical disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• > 65 years old

• French mother tongue

• Good vision with or without correction

• Alzheimer's or related disease (15 <Mini-Mental State Examination<25)

• Affiliate or beneficiary of a social security

• Informed consent

Exclusion Criteria:

• Cognitive disorders related to another pathology (cerebrovascular accident, head trauma, epilepsy ...)

• Protected patient (under guardianship) or person deprived of liberty by judicial or administrative decision

Related Conditions & MeSH terms

• Alzheimer Disease
• Lexical Syntactic Disorder
• Presbycusis

Intervention

Other:
• Speech therapy
During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Link Between Lack of Word and Presbycusis	The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items, score range from 0 to 42) and of verbs (28 items, score range from 0 to 28). The results are presented in a report including scores, description of qualitative errors, and results per item. A global score of less than 40 indicates a lack of words. The score range is between 0 and 70.; The hearing questionnaire consists in 14 questions about concrete situations and a direct question about what the patient thinks of his hearing. Answers are quoted 0, 2 or 4 points. An overall score greater than 14 indicates presbycusis.	at inclusion
Secondary	Association Between Age and Lack of Word	Age of patients and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Gender and Lack of Word	Male or female and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Study Level and Lack of Word	Primary (certificate study), secondary and tertiary study (baccalaureat and more) level and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Accommodation Type and Lack of Word	Patient living at home or in an institution and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Laterality and Lack of Word	Right or left handed patients and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Main Diagnosis and Lack of Word	Alzheimer's disease or related disease and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Hearing Aid and Lack of Word	Patients with or without hearing aid and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion
Secondary	Association Between Speech Therapy and Lack of Word	Patients with or without ongoing speech therapy and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.	at inclusion