- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638323
Age-related Hearing Loss and Lexical Disorders (LOOP)
Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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La Rochelle, France
- Groupe Hospitalier de la Rochelle Ré Aunis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LOOP group
Speech therapy consultation for patients with Alzheimer's disease
|
During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Link Between Lack of Word and Presbycusis
Time Frame: at inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association Between Age and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Gender and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Study Level and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Accommodation Type and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Laterality and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Main Diagnosis and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Hearing Aid and Lack of Word
Time Frame: at inclusion
|
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
|
Association Between Speech Therapy and Lack of Word
Time Frame: at inclusion
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Marie-Laure Vignaud, Ph.D., Groupe Hospitalier de la Rochelle Ré Aunis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurocognitive Disorders
- Otorhinolaryngologic Diseases
- Neurodegenerative Diseases
- Ear Diseases
- Dementia
- Tauopathies
- Sensation Disorders
- Hearing Disorders
- Hearing Loss, Sensorineural
- Hearing Loss
- Alzheimer Disease
- Presbycusis
Other Study ID Numbers
- 2018/P08/256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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