Deafness and Cognition in Middle-aged Adults (SURDICOG)
Primary Purpose
Mild Cognitive Impairment in Middle-aged Adults
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive and audiometry evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Cognitive Impairment in Middle-aged Adults focused on measuring Severe and profound hearing loss, mild cognitive impairment (MCI), middle aged adult, depression
Eligibility Criteria
Inclusion Criteria:
- Cases: Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL, current in french
- Controls: normal hearing subjects matched on age, sex and education level
Exclusion Criteria:
- Associated disability that prevents the tests from being performed
- Past and current history of neurological and psychiatric disorders including meningitis
- Psychotropic drug treatment
- Vulnerable subject
Sites / Locations
- Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-SalpêtrièreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cases: Patients with severe to profound hearing loss
Controls: 90 matched subjects with normal hearing
Arm Description
Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL
Healthy controls aged between 45 to 64 years with normal hearing on pure-tone audiometry (as function of ISO 7029 reference)
Outcomes
Primary Outcome Measures
Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing
test to assess cognitive impairment. Result of this test is expressed on 30 points and is analyzed in function of age, sex, education level depending on publicised norms.
Evaluation of Trail making tests (TMT) A et B to evaluate executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
Trail making tests (TMT) A et B: rapidity test to evaluate executive functions. Score is expressed correct displacement number (in A and B parts) divided by time and multiply by ten.
Evaluation of "Fluences verbales sémantique et phonémique" to evaluate linguistic skills in patients with severe to profound hearing loss compare to subjects with normal hearing
"Fluences verbales sémantique et phonémique": test to evaluate linguistic skills. Score correspond to the number of words cited in 60 minutes in a specific category.
Evaluation of 16-item Free and Cue Selective Recall Test (RLRI/16) to evaluate episodic memory in patients with severe to profound hearing loss compare to subjects with normal hearing
16-item Free and Cue Selective Recall Test (RLRI/16): test adapted in French from the Free and Cue Selective Reminding test (FCSRT) assessing episodic memory. After an encoding phase during which the subject reads and memorizes 16 words 4 by 4, the subject is asked to freely recall as many words as possible in 2 minutes, cues are then provided. The free and cue recall is repeated 3 times and then 20 minutes later (delayed recall). The score used in the study will be: sum of the immediate free recall of the first three trials (0 to 48) and score of the delayed free recall (0 to 16)
Evaluation of Digit Symbol Substitution Test to evaluate psychomotor speed and executive functions, executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
Digit Symbol Substitution Test (DSST) of the Weschsler Adult Intelligence Scale-IV (WAIS-IV): test assessing attention, psychomotor speed and executive functions, executive functions. This test presents a matrix of nine digit-symbol pairs on a sheet of paper. A list of 135 numbers is presented in random order. The subject must associate the symbol corresponding to the number as quickly as possible by following the matrix. The score used will be: number of correctly associated symbols in 90 seconds
Evaluation of Instrumental activities of daily living scale to evaluate the level of dependence of dependence of the subjects in patients with severe to profound hearing loss compare to subjects with normal hearing
Instrumental activities of daily living scale (IADL): evaluation of the level of dependence of dependence of the subjects [45] (addendum 2). Patients with MCI must remain independent. The existence of dependence contributes to the diagnosis of of dementia
Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing
Assessment or monitoring to be instituted for a score of 3 or more, and/or one "yes" answer to question 5, and/or two "yes" answers to questions: A,4,5,7,8.
Secondary Outcome Measures
Type of MCI
Evaluate the type of MCI (amnesic, dysexecutive, multidomain)
Impact of the severity of the hearing loss on presence and severity of cognitive disorders
Subjective evaluation of hearing noise based on Speech and spatial questionnary : Patients have to mark a scale, for example with a cross, at the right place between 0 and 10. A mark on the value 10 means that he is perfectly capable of doing or experiencing what is described in the corresponding question. A mark on the 0 indicates that he/she is hardly able to do or experience what is described.
Full Information
NCT ID
NCT05149742
First Posted
October 28, 2021
Last Updated
October 28, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05149742
Brief Title
Deafness and Cognition in Middle-aged Adults
Acronym
SURDICOG
Official Title
Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
November 24, 2025 (Anticipated)
Study Completion Date
November 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.
Detailed Description
This case-control study will include 180 middle aged adults (90 cases, 90 healthy controls) matched on sex, age, education level in order to find an association between severe and profound hearing loss and presence of mild cognitive impairment.
90 subjects with severe to profound hearing loss,, with a maximum speech intelligibility of 70% for Fournier's disyllabic words in silence with properly fitted hearing aids could be included. Cognition evaluated on a battery of 5 tests, depression and dependance will be compared to healthy controls with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) The subjects (cases and controls) will be recruited in the ENT consultation from the Cochlear Implant Center (Unité fonctionnelle implants auditifs, Pitié-Salpêtrière Hospital, Head: Dr Isabelle Mosnier)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment in Middle-aged Adults
Keywords
Severe and profound hearing loss, mild cognitive impairment (MCI), middle aged adult, depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases: Patients with severe to profound hearing loss
Arm Type
Experimental
Arm Description
Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL
Arm Title
Controls: 90 matched subjects with normal hearing
Arm Type
Active Comparator
Arm Description
Healthy controls aged between 45 to 64 years with normal hearing on pure-tone audiometry (as function of ISO 7029 reference)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and audiometry evaluation
Intervention Description
For both Patients and controls:
Cognitive functions evaluation
Tonal and vocal audiometry
Self questionnaires
Primary Outcome Measure Information:
Title
Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
test to assess cognitive impairment. Result of this test is expressed on 30 points and is analyzed in function of age, sex, education level depending on publicised norms.
Time Frame
1 day
Title
Evaluation of Trail making tests (TMT) A et B to evaluate executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
Trail making tests (TMT) A et B: rapidity test to evaluate executive functions. Score is expressed correct displacement number (in A and B parts) divided by time and multiply by ten.
Time Frame
1 day
Title
Evaluation of "Fluences verbales sémantique et phonémique" to evaluate linguistic skills in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
"Fluences verbales sémantique et phonémique": test to evaluate linguistic skills. Score correspond to the number of words cited in 60 minutes in a specific category.
Time Frame
1 day
Title
Evaluation of 16-item Free and Cue Selective Recall Test (RLRI/16) to evaluate episodic memory in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
16-item Free and Cue Selective Recall Test (RLRI/16): test adapted in French from the Free and Cue Selective Reminding test (FCSRT) assessing episodic memory. After an encoding phase during which the subject reads and memorizes 16 words 4 by 4, the subject is asked to freely recall as many words as possible in 2 minutes, cues are then provided. The free and cue recall is repeated 3 times and then 20 minutes later (delayed recall). The score used in the study will be: sum of the immediate free recall of the first three trials (0 to 48) and score of the delayed free recall (0 to 16)
Time Frame
1 day
Title
Evaluation of Digit Symbol Substitution Test to evaluate psychomotor speed and executive functions, executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
Digit Symbol Substitution Test (DSST) of the Weschsler Adult Intelligence Scale-IV (WAIS-IV): test assessing attention, psychomotor speed and executive functions, executive functions. This test presents a matrix of nine digit-symbol pairs on a sheet of paper. A list of 135 numbers is presented in random order. The subject must associate the symbol corresponding to the number as quickly as possible by following the matrix. The score used will be: number of correctly associated symbols in 90 seconds
Time Frame
1 day
Title
Evaluation of Instrumental activities of daily living scale to evaluate the level of dependence of dependence of the subjects in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
Instrumental activities of daily living scale (IADL): evaluation of the level of dependence of dependence of the subjects [45] (addendum 2). Patients with MCI must remain independent. The existence of dependence contributes to the diagnosis of of dementia
Time Frame
1 day
Title
Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing
Description
Assessment or monitoring to be instituted for a score of 3 or more, and/or one "yes" answer to question 5, and/or two "yes" answers to questions: A,4,5,7,8.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Type of MCI
Description
Evaluate the type of MCI (amnesic, dysexecutive, multidomain)
Time Frame
1 day
Title
Impact of the severity of the hearing loss on presence and severity of cognitive disorders
Description
Subjective evaluation of hearing noise based on Speech and spatial questionnary : Patients have to mark a scale, for example with a cross, at the right place between 0 and 10. A mark on the value 10 means that he is perfectly capable of doing or experiencing what is described in the corresponding question. A mark on the 0 indicates that he/she is hardly able to do or experience what is described.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cases: Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL, current in french
Controls: normal hearing subjects matched on age, sex and education level
Exclusion Criteria:
Associated disability that prevents the tests from being performed
Past and current history of neurological and psychiatric disorders including meningitis
Psychotropic drug treatment
Vulnerable subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Dr MOSNIER, MD
Phone
142162612
Ext
+33
Email
isabelle.mosnier@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nassima SCHMOLL
Phone
142163089
Ext
+33
Email
nassima.schmoll@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Dr MOSNIER, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Dr MOSNIER, MD
Phone
142162612
Ext
+33
Email
isabelle.mosnier@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be collected and analysed into the GH Pitié-Salpêtrière (AP-HP)
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Deafness and Cognition in Middle-aged Adults
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