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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 : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

Tracking Information
First Submitted Date August 14, 2018
First Posted Date August 20, 2018
Results First Submitted Date May 13, 2019
Results First Posted Date September 11, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date August 27, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 2, 2019)
Link Between Lack of Word and Presbycusis [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: August 17, 2018)
Link Between Lack of Word and Presbycusis [ Time Frame: 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. 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.
Change History Complete list of historical versions of study NCT03638323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 2, 2019)
  • Association Between Age and Lack of Word [ Time Frame: 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.
  • Association Between Gender and Lack of Word [ Time Frame: 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.
  • Association Between Study Level and Lack of Word [ Time Frame: 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.
  • Association Between Accommodation Type and Lack of Word [ Time Frame: 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.
  • Association Between Laterality and Lack of Word [ Time Frame: 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.
  • Association Between Main Diagnosis and Lack of Word [ Time Frame: 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.
  • Association Between Hearing Aid and Lack of Word [ Time Frame: 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.
  • Association Between Speech Therapy and Lack of Word [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: August 17, 2018)
  • Association Between Age and Lack of Word [ Time Frame: at inclusion ]
    Age of patients and score at the lack of word questionnaire (BIMM)
  • Association Between Gender and Lack of Word [ Time Frame: at inclusion ]
    Male or female and score at the lack of word questionnaire (BIMM)
  • Association Between Study Level and Lack of Word [ Time Frame: at inclusion ]
    Primary, secondary or tertiary study level and score at the lack of word questionnaire (BIMM)
  • Association Between Accommodation Type and Lack of Word [ Time Frame: at inclusion ]
    Patient living at home or in an institution and score at the lack of word questionnaire (BIMM)
  • Association Between Laterality and Lack of Word [ Time Frame: at inclusion ]
    Right or left handed patients and score at the lack of word questionnaire (BIMM)
  • Association Between Main Diagnosis and Lack of Word [ Time Frame: at inclusion ]
    Alzheimer's disease or related disease and score at the lack of word questionnaire (BIMM)
  • Association Between Hearing Aid and Lack of Word [ Time Frame: at inclusion ]
    Patients with or without hearing aid and score at the lack of word questionnaire (BIMM)
  • Association Between Speech Therapy and Lack of Word [ Time Frame: at inclusion ]
    Patients with or without ongoing speech therapy and score at the lack of word questionnaire (BIMM)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Age-related Hearing Loss and Lexical Disorders
Official Title Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Alzheimer Disease
  • Presbycusis
  • Lexical Syntactic Disorder
Intervention 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
Study Groups/Cohorts LOOP group
Speech therapy consultation for patients with Alzheimer's disease
Intervention: Other: Speech therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2019)
46
Original Estimated Enrollment
 (submitted: August 17, 2018)
45
Actual Study Completion Date January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03638323
Other Study ID Numbers 2018/P08/256
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Groupe Hospitalier de la Rochelle Ré Aunis
Study Sponsor Groupe Hospitalier de la Rochelle Ré Aunis
Collaborators Not Provided
Investigators
Study Director: Marie-Laure Vignaud, Ph.D. Groupe Hospitalier de la Rochelle Ré Aunis
PRS Account Groupe Hospitalier de la Rochelle Ré Aunis
Verification Date August 2019