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Age-related Hearing Loss and Lexical Disorders

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03638323
Acronym
LOOP
Enrollment
46
Registered
2018-08-20
Start date
2018-08-27
Completion date
2019-01-31
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Lexical Syntactic Disorder, Presbycusis

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.

Interventions

OTHERSpeech therapy

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

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Link Between Lack of Word and Presbycusisat inclusionThe 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

MeasureTime frameDescription
Association Between Age and Lack of Wordat inclusionAge 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.
Association Between Gender and Lack of Wordat inclusionMale 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.
Association Between Study Level and Lack of Wordat inclusionPrimary (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.
Association Between Accommodation Type and Lack of Wordat inclusionPatient 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.
Association Between Laterality and Lack of Wordat inclusionRight 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.
Association Between Main Diagnosis and Lack of Wordat inclusionAlzheimer'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.
Association Between Hearing Aid and Lack of Wordat inclusionPatients 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.
Association Between Speech Therapy and Lack of Wordat inclusionPatients 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.

Countries

France

Contacts

STUDY_DIRECTORMarie-Laure Vignaud, Ph.D.

Groupe Hospitalier de la Rochelle Ré Aunis

Participant flow

Pre-assignment details

Number of screend patients: 46 Number of patient excluded: 9 * 1 refusal * 7 lack an inclusion criteria or had an exclusion criteria * 1 was excluded after enrolment due to comprehension disorders and unreliable responses to the Hearing Questionnaire

Participants by arm

ArmCount
Normal Hearing
Participants were divided into two groups based on their score on the Hearing Questionnaire. Patients with a score of less than 14 are in the normal hearing group
29
Risk of Presbycusis
Participants were divided into two groups based on their score on the Hearing Questionnaire. Patients with a score of 14 or more are in the risk of presbycusis group
8
Total37

Baseline characteristics

CharacteristicTotalNormal HearingRisk of Presbycusis
Age, Continuous79 years78 years80.5 years
Diagnostic
Alzheimer's disease
10 Participants7 Participants3 Participants
Diagnostic
Related disease
27 Participants22 Participants5 Participants
Educational level
baccalaureat or more
14 Participants11 Participants3 Participants
Educational level
Certificate study
23 Participants18 Participants5 Participants
Hearing aid
no
34 Participants28 Participants6 Participants
Hearing aid
yes
3 Participants1 Participants2 Participants
Laterality
left handed
3 Participants3 Participants0 Participants
Laterality
right handed
34 Participants26 Participants8 Participants
Race and Ethnicity Not Collected0 Participants
Residency
At home
36 Participants29 Participants7 Participants
Residency
Institution
1 Participants0 Participants1 Participants
Sex: Female, Male
Female
25 Participants19 Participants6 Participants
Sex: Female, Male
Male
12 Participants10 Participants2 Participants
Speech and language therapy
no
27 Participants23 Participants4 Participants
Speech and language therapy
yes
10 Participants6 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 37
other
Total, other adverse events
0 / 37
serious
Total, serious adverse events
0 / 37

Outcome results

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.

Time frame: at inclusion

ArmMeasureGroupValue (MEDIAN)
Normal HearingLink Between Lack of Word and PresbycusisGlobal score38 score on a scale
Normal HearingLink Between Lack of Word and PresbycusisScore at denomination of nouns23 score on a scale
Normal HearingLink Between Lack of Word and PresbycusisScore at denomination of verbs15 score on a scale
Risk of PresbycusisLink Between Lack of Word and PresbycusisGlobal score38.5 score on a scale
Risk of PresbycusisLink Between Lack of Word and PresbycusisScore at denomination of nouns21.5 score on a scale
Risk of PresbycusisLink Between Lack of Word and PresbycusisScore at denomination of verbs17 score on a scale
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Accommodation Type and Lack of WordAt home15 Participants
Normal HearingAssociation Between Accommodation Type and Lack of WordInstitution1 Participants
Risk of PresbycusisAssociation Between Accommodation Type and Lack of WordAt home21 Participants
Risk of PresbycusisAssociation Between Accommodation Type and Lack of WordInstitution0 Participants
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.

Time frame: at inclusion

ArmMeasureValue (MEDIAN)
Normal HearingAssociation Between Age and Lack of Word76 years
Risk of PresbycusisAssociation Between Age and Lack of Word80 years
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Gender and Lack of WordFemale7 Participants
Normal HearingAssociation Between Gender and Lack of WordMale9 Participants
Risk of PresbycusisAssociation Between Gender and Lack of WordFemale18 Participants
Risk of PresbycusisAssociation Between Gender and Lack of WordMale3 Participants
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Hearing Aid and Lack of Wordyes0 Participants
Normal HearingAssociation Between Hearing Aid and Lack of Wordno16 Participants
Risk of PresbycusisAssociation Between Hearing Aid and Lack of Wordyes3 Participants
Risk of PresbycusisAssociation Between Hearing Aid and Lack of Wordno18 Participants
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Laterality and Lack of WordRight handed16 Participants
Normal HearingAssociation Between Laterality and Lack of WordLeft handed0 Participants
Risk of PresbycusisAssociation Between Laterality and Lack of WordRight handed18 Participants
Risk of PresbycusisAssociation Between Laterality and Lack of WordLeft handed3 Participants
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Main Diagnosis and Lack of WordAlzheimer's disease3 Participants
Normal HearingAssociation Between Main Diagnosis and Lack of WordRelated disease13 Participants
Risk of PresbycusisAssociation Between Main Diagnosis and Lack of WordAlzheimer's disease7 Participants
Risk of PresbycusisAssociation Between Main Diagnosis and Lack of WordRelated disease14 Participants
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Speech Therapy and Lack of Wordyes5 Participants
Normal HearingAssociation Between Speech Therapy and Lack of Wordno11 Participants
Risk of PresbycusisAssociation Between Speech Therapy and Lack of Wordyes5 Participants
Risk of PresbycusisAssociation Between Speech Therapy and Lack of Wordno16 Participants
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.

Time frame: at inclusion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Normal HearingAssociation Between Study Level and Lack of WordPrimary level6 Participants
Normal HearingAssociation Between Study Level and Lack of WordSecondary & tertiary level10 Participants
Risk of PresbycusisAssociation Between Study Level and Lack of WordPrimary level17 Participants
Risk of PresbycusisAssociation Between Study Level and Lack of WordSecondary & tertiary level4 Participants

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026