ClinicalTrials.gg
CompletedNCT03638323LOOPUpdated Mar 19, 2026Results posted

Age-related Hearing Loss and Lexical Disorders

An observational study in Alzheimer Disease, Presbycusis and Lexical Syntactic Disorder, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
46
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease
  • Presbycusis
  • Lexical Syntactic Disorder
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's enrollment of 46 is below the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Series of patients from the Care Center for the Elderly (geriatric day hospital, long-term care units, follow-up care units and rehabilitation)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 65 years old
  • French mother tongue
  • Good vision with or without correction
  • Alzheimer's or related disease (15 \<\<25)
  • Affiliate or beneficiary of a social security

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No

Groups and cohorts

  • LOOP group

    Speech therapy consultation for patients with Alzheimer's disease

    Other: Speech therapy

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Results

Posted Sep 11, 2019

Participant flow

Participant flow — Overall Study
MilestoneLOOP Group
Started38
Completed37
Not completed1

Outcome measures

PrimaryLink 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
Reported as:
Median · score on a scale
Link Between Lack of Word and Presbycusis
score on a scaleNormal HearingRisk of Presbycusis
Global score38 (21 to 50)38.5 (24 to 50)
Score at denomination of nouns23 (12 to 30)21.5 (15 to 32)
Score at denomination of verbs15 (9 to 20)17 (9 to 19)
SecondaryAssociation 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
Reported as:
Median · years
Association Between Age and Lack of Word
yearsNo Word AlterationLack of Word
Association Between Age and Lack of Word76 (68 to 87)80 (72 to 86)
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Gender and Lack of Word
ParticipantsNo Word AlterationLack of Word
Female718
Male93
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Study Level and Lack of Word
ParticipantsNo Word AlterationLack of Word
Primary level617
Secondary & tertiary level104
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Accommodation Type and Lack of Word
ParticipantsNo Word AlterationLack of Word
At home1521
Institution10
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Laterality and Lack of Word
ParticipantsNo Word AlterationLack of Word
Right handed1618
Left handed03
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Main Diagnosis and Lack of Word
ParticipantsNo Word AlterationLack of Word
Alzheimer's disease37
Related disease1314
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Hearing Aid and Lack of Word
ParticipantsNo Word AlterationLack of Word
yes03
no1618
SecondaryAssociation 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
Reported as:
Count of participants · Participants
Association Between Speech Therapy and Lack of Word
ParticipantsNo Word AlterationLack of Word
yes55
no1116

Adverse events

Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LOOP Group0/37 (0%)0/37 (0%)0/37 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Normal HearingRisk of PresbycusisTotal
Median78 (68 to 87)80.5 (71 to 86)79 (68 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Normal HearingRisk of PresbycusisTotal
Female19625
Male10212
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Normal HearingRisk of PresbycusisTotal
Count of participants——0
Educational level
Educational level(Participants)Normal HearingRisk of PresbycusisTotal
Certificate study18523
baccalaureat or more11314
Residency
Residency(Participants)Normal HearingRisk of PresbycusisTotal
At home29736
Institution011
Laterality
Laterality(Participants)Normal HearingRisk of PresbycusisTotal
left handed303
right handed26834
Diagnostic
Diagnostic(Participants)Normal HearingRisk of PresbycusisTotal
Alzheimer's disease7310
Related disease22527
Hearing aid
Hearing aid(Participants)Normal HearingRisk of PresbycusisTotal
yes123
no28634

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Groupe Hospitalier de la Rochelle Ré Aunis
    La Rochelle, France
09

References and documents

Publications

  • Camille Roche, Aude Bournazel, Caroline Allix-Béguec, Marie-Laure Pinon-Vignaud. Étude pilote des liens entre la presbyacousie et les troubles lexicaux chez les patients atteints de maladie d'Alzheimer ou maladie apparentée. Audiology Direct. September 2020. DOI: 10.1051/audiodir/202004002

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Jan 2019, 5 months.

Results were first posted in Sep 2019, 7 months after primary completion.

Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's 5 months is below that.

Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2018
First posted
Aug 20, 2018
StartActual
Aug 27, 2018
Primary completionActual
Jan 31, 2019
CompletionActual
Jan 31, 2019
Results first posted
Sep 11, 2019
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03638323
Lead sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Responsible party
Sponsor
First posted
Aug 20, 2018
Start date
Aug 27, 2018
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Results posted
Sep 11, 2019
Last update
Mar 19, 2026

Study contacts

Marie-Laure Vignaud, Ph.D.
study director · Groupe Hospitalier de la Rochelle Ré Aunis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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