LOOP: Age-related Hearing Loss and Lexical Disorders

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03638323
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Actual Duration (Months): 5.2
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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	Phase
Alzheimer Disease; Presbycusis; Lexical Syntactic Disorder	Other: Speech therapy

Study Design

• 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: Aug 27, 2018
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Link Between Lack of Word and Presbycusis [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle		France

Sponsors and Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis

Investigators

• Study Director: Marie-Laure Vignaud, Ph.D., Groupe Hospitalier de la Rochelle Ré Aunis

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 8, 2018

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
• ClinicalTrials.gov Identifier: NCT03638323
• Other Study ID Numbers: 2018/P08/256
• First Posted: Aug 20, 2018
• Last Update Posted: Dec 5, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Presbycusis; Alzheimer Disease

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Normal Hearing	Risk of Presbycusis	Total
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 Participants	29	8	37
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	78	80.5	79
Sex: Female, Male (Count of Participants)
Female	19 65.5%	6 75%	25 67.6%
Male	10 34.5%	2 25%	12 32.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Educational level (Count of 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 (Count of Participants)
At home	29 100%	7 87.5%	36 97.3%
Institution	0 0%	1 12.5%	1 2.7%
Laterality (Count of Participants)
left handed	3 10.3%	0 0%	3 8.1%
right handed	26 89.7%	8 100%	34 91.9%
Diagnostic (Count of Participants)
Alzheimer's disease	7 24.1%	3 37.5%	10 27%
Related disease	22 75.9%	5 62.5%	27 73%
Hearing aid (Count of Participants)
yes	1 3.4%	2 25%	3 8.1%
no	28 96.6%	6 75%	34 91.9%
Speech and language therapy (Count of Participants)
yes	6 20.7%	4 50%	10 27%
no	23 79.3%	4 50%	27 73%

Outcome Measures

1. Primary Outcome

Title	Link Between Lack of Word and Presbycusis
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Hearing	Risk of Presbycusis
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
Measure Participants	29	8
Global score	38	38.5
Score at denomination of nouns	23	21.5
Score at denomination of verbs	15	17

2. Secondary Outcome

Title	Association Between Age and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	19	24
Median (Full Range) [years]	76	80

3. Secondary Outcome

Title	Association Between Gender and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
Female	7 24.1%	18 225%
Male	9 31%	3 37.5%

4. Secondary Outcome

Title	Association Between Study Level and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
Primary level	6 20.7%	17 212.5%
Secondary & tertiary level	10 34.5%	4 50%

5. Secondary Outcome

Title	Association Between Accommodation Type and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
At home	15 51.7%	21 262.5%
Institution	1 3.4%	0 0%

6. Secondary Outcome

Title	Association Between Laterality and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
Right handed	16 55.2%	18 225%
Left handed	0 0%	3 37.5%

7. Secondary Outcome

Title	Association Between Main Diagnosis and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
Alzheimer's disease	3 10.3%	7 87.5%
Related disease	13 44.8%	14 175%

8. Secondary Outcome

Title	Association Between Hearing Aid and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
yes	0 0%	3 37.5%
no	16 55.2%	18 225%

9. Secondary Outcome

Title	Association Between Speech Therapy and Lack of Word
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Word Alteration	Lack of Word
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
Measure Participants	16	21
yes	5 17.2%	5 62.5%
no	11 37.9%	16 200%

Adverse Events

Time Frame	5 months
Arm/Group Title	LOOP Group
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 (%)	# Events
Total	0/37 (0%)
Serious Adverse Events
	LOOP Group
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Other (Not Including Serious) Adverse Events
	LOOP Group
	Affected / at Risk (%)	# Events
Total	0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.