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.

Recruitment status

COMPLETED

Target enrollment

46 participants

Primary outcome timeframe

at inclusion

Results posted on

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: +33 (0)5 46 45 63 70

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place