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Age-related Hearing Loss and Lexical Disorders (LOOP)

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ClinicalTrials.gov Identifier: NCT03638323
Recruitment Status : Completed
First Posted : August 20, 2018
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

Brief 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.


Condition or disease Intervention/treatment
Alzheimer Disease Presbycusis Lexical Syntactic Disorder Other: Speech therapy

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019


Group/Cohort Intervention/treatment
LOOP group
Speech therapy consultation for patients with Alzheimer's disease
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Series of patients from the Care Center for the Elderly (geriatric day hospital, long-term care units, follow-up care units and rehabilitation)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638323


Locations
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France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
Investigators
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Study Director: Marie-Laure Vignaud, Ph.D. Groupe Hospitalier de la Rochelle Ré Aunis
  Study Documents (Full-Text)

Documents provided by Groupe Hospitalier de la Rochelle Ré Aunis:

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Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT03638323     History of Changes
Other Study ID Numbers: 2018/P08/256
First Posted: August 20, 2018    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbycusis
Alzheimer Disease
Disease
Pathologic Processes
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms