Trial Outcomes & Findings for Age-related Hearing Loss and Lexical Disorders (NCT NCT03638323)
NCT ID: NCT03638323
Last Updated: 2026-03-19
Results Overview
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.
COMPLETED
46 participants
at inclusion
2026-03-19
Participant Flow
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
Participant milestones
| Measure |
LOOP Group
Speech therapy consultation for patients with Alzheimer's disease
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
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Normal Hearing
n=29 Participants
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
|
Risk of Presbycusis
n=8 Participants
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
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78 years
n=29 Participants
|
80.5 years
n=8 Participants
|
79 years
n=37 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=29 Participants
|
6 Participants
n=8 Participants
|
25 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=29 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Educational level
Certificate study
|
18 Participants
n=29 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=37 Participants
|
|
Educational level
baccalaureat or more
|
11 Participants
n=29 Participants
|
3 Participants
n=8 Participants
|
14 Participants
n=37 Participants
|
|
Residency
At home
|
29 Participants
n=29 Participants
|
7 Participants
n=8 Participants
|
36 Participants
n=37 Participants
|
|
Residency
Institution
|
0 Participants
n=29 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=37 Participants
|
|
Laterality
left handed
|
3 Participants
n=29 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=37 Participants
|
|
Laterality
right handed
|
26 Participants
n=29 Participants
|
8 Participants
n=8 Participants
|
34 Participants
n=37 Participants
|
|
Diagnostic
Alzheimer's disease
|
7 Participants
n=29 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=37 Participants
|
|
Diagnostic
Related disease
|
22 Participants
n=29 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=37 Participants
|
|
Hearing aid
yes
|
1 Participants
n=29 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=37 Participants
|
|
Hearing aid
no
|
28 Participants
n=29 Participants
|
6 Participants
n=8 Participants
|
34 Participants
n=37 Participants
|
|
Speech and language therapy
yes
|
6 Participants
n=29 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=37 Participants
|
|
Speech and language therapy
no
|
23 Participants
n=29 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=29 Participants
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
|
Risk of Presbycusis
n=8 Participants
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
|
|---|---|---|
|
Link Between Lack of Word and Presbycusis
Global score
|
38 score on a scale
Interval 21.0 to 50.0
|
38.5 score on a scale
Interval 24.0 to 50.0
|
|
Link Between Lack of Word and Presbycusis
Score at denomination of nouns
|
23 score on a scale
Interval 12.0 to 30.0
|
21.5 score on a scale
Interval 15.0 to 32.0
|
|
Link Between Lack of Word and Presbycusis
Score at denomination of verbs
|
15 score on a scale
Interval 9.0 to 20.0
|
17 score on a scale
Interval 9.0 to 19.0
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=19 Participants
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
|
Risk of Presbycusis
n=24 Participants
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
|
|---|---|---|
|
Association Between Age and Lack of Word
|
76 years
Interval 68.0 to 87.0
|
80 years
Interval 72.0 to 86.0
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Gender and Lack of Word
Male
|
9 Participants
|
3 Participants
|
|
Association Between Gender and Lack of Word
Female
|
7 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Study Level and Lack of Word
Primary level
|
6 Participants
|
17 Participants
|
|
Association Between Study Level and Lack of Word
Secondary & tertiary level
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Accommodation Type and Lack of Word
At home
|
15 Participants
|
21 Participants
|
|
Association Between Accommodation Type and Lack of Word
Institution
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Laterality and Lack of Word
Right handed
|
16 Participants
|
18 Participants
|
|
Association Between Laterality and Lack of Word
Left handed
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Main Diagnosis and Lack of Word
Alzheimer's disease
|
3 Participants
|
7 Participants
|
|
Association Between Main Diagnosis and Lack of Word
Related disease
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Hearing Aid and Lack of Word
yes
|
0 Participants
|
3 Participants
|
|
Association Between Hearing Aid and Lack of Word
no
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: at 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.
Outcome measures
| Measure |
Normal Hearing
n=16 Participants
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
|
Risk of Presbycusis
n=21 Participants
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
|
|---|---|---|
|
Association Between Speech Therapy and Lack of Word
yes
|
5 Participants
|
5 Participants
|
|
Association Between Speech Therapy and Lack of Word
no
|
11 Participants
|
16 Participants
|
Adverse Events
LOOP Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marie-Laure Vignaud, neuropsychologist
Groupe Hospitalier de la Rochelle Ré Aunis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place