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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 : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Alzheimer Disease
Presbycusis
Lexical Syntactic Disorder
Intervention Other: Speech therapy
Enrollment 46
Recruitment Details  
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
Arm/Group Title LOOP Group
Hide Arm/Group Description

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

Period Title: Overall Study
Started 38
Completed 37
Not Completed 1
Arm/Group Title Normal Hearing Risk of Presbycusis Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 29 8 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants 8 participants 37 participants
78
(68 to 87)
80.5
(71 to 86)
79
(68 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
Female
19
  65.5%
6
  75.0%
25
  67.6%
Male
10
  34.5%
2
  25.0%
12
  32.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Educational level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
Certificate study
18
  62.1%
5
  62.5%
23
  62.2%
baccalaureat or more
11
  37.9%
3
  37.5%
14
  37.8%
Residency  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
At home
29
 100.0%
7
  87.5%
36
  97.3%
Institution
0
   0.0%
1
  12.5%
1
   2.7%
Laterality  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
left handed
3
  10.3%
0
   0.0%
3
   8.1%
right handed
26
  89.7%
8
 100.0%
34
  91.9%
Diagnostic  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
Alzheimer's disease
7
  24.1%
3
  37.5%
10
  27.0%
Related disease
22
  75.9%
5
  62.5%
27
  73.0%
Hearing aid  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
yes
1
   3.4%
2
  25.0%
3
   8.1%
no
28
  96.6%
6
  75.0%
34
  91.9%
Speech and language therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
yes
6
  20.7%
4
  50.0%
10
  27.0%
no
23
  79.3%
4
  50.0%
27
  73.0%
1.Primary Outcome
Title Link Between Lack of Word and Presbycusis
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Hearing Risk of Presbycusis
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 29 8
Median (Full Range)
Unit of Measure: score on a scale
Global score
38
(21 to 50)
38.5
(24 to 50)
Score at denomination of nouns
23
(12 to 30)
21.5
(15 to 32)
Score at denomination of verbs
15
(9 to 20)
17
(9 to 19)
2.Secondary Outcome
Title Association Between Age and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 19 24
Median (Full Range)
Unit of Measure: years
76
(68 to 87)
80
(72 to 86)
3.Secondary Outcome
Title Association Between Gender and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
Female
7
  43.8%
18
  85.7%
Male
9
  56.3%
3
  14.3%
4.Secondary Outcome
Title Association Between Study Level and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
Primary level
6
  37.5%
17
  81.0%
Secondary & tertiary level
10
  62.5%
4
  19.0%
5.Secondary Outcome
Title Association Between Accommodation Type and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
At home
15
  93.8%
21
 100.0%
Institution
1
   6.3%
0
   0.0%
6.Secondary Outcome
Title Association Between Laterality and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
Right handed
16
 100.0%
18
  85.7%
Left handed
0
   0.0%
3
  14.3%
7.Secondary Outcome
Title Association Between Main Diagnosis and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
Alzheimer's disease
3
  18.8%
7
  33.3%
Related disease
13
  81.3%
14
  66.7%
8.Secondary Outcome
Title Association Between Hearing Aid and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
yes
0
   0.0%
3
  14.3%
no
16
 100.0%
18
  85.7%
9.Secondary Outcome
Title Association Between Speech Therapy and Lack of Word
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Word Alteration Lack of Word
Hide Arm/Group Description:
Patients with a score of 40 or more at the BIMM questionnaire are in the "no word alteration" group
Patients with a score of less than 40 at the BIMM questionnaire are in the "lack of word" group
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
yes
5
  31.3%
5
  23.8%
no
11
  68.8%
16
  76.2%
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LOOP Group
Hide Arm/Group Description

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

All-Cause Mortality
LOOP Group
Affected / at Risk (%)
Total   0/37 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LOOP Group
Affected / at Risk (%)
Total   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LOOP Group
Affected / at Risk (%)
Total   0/37 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marie-Laure Vignaud, neuropsychologist
Organization: Groupe Hospitalier de la Rochelle Ré Aunis
Phone: +33 (0)5 46 45 63 70
EMail: marie-laure.vignaud@ght-atlantique17.fr
Layout table for additonal information
Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT03638323     History of Changes
Other Study ID Numbers: 2018/P08/256
First Submitted: August 14, 2018
First Posted: August 20, 2018
Results First Submitted: May 13, 2019
Results First Posted: September 11, 2019
Last Update Posted: December 5, 2019