Mild Cognitive Impairment in Middle-aged AdultsSURDICOGNCT05149742
Deafness and Cognition in Middle-aged Adults
A study testing Cognitive and audiometry evaluation in people with Mild Cognitive Impairment in Middle-aged Adults, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment in Middle-aged Adults
- What is being tested?
- Cognitive and audiometry evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2022to 24 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Isabelle Dr MOSNIER, MD, 142162612 ext. +33, isabelle.mosnier@aphp.fr
About this study
Official title: Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
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.
Read the 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)
- Being tested
- Cognitive and audiometry evaluation
- Keywords
- Severe and profound hearing loss, mild cognitive impairment (MCI), middle aged adult, depression
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and audiometry evaluationBehavioural
For both Patients and controls:
- Cognitive functions evaluation
- Tonal and vocal audiometry
- Self questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Cases: Patients with severe to profound hearing loss | Experimental | 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 Receives: Behavioral: Cognitive and audiometry evaluation |
| Controls: 90 matched subjects with normal hearing | Active comparator | Healthy controls aged between 45 to 64 years with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) Receives: Behavioral: Cognitive and audiometry evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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)
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (2)
Type of MCI
Evaluate the type of MCI (amnesic, dysexecutive, multidomain)
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start24 May 2022
- Primary completion24 May 2027 (estimated)
- Study completion24 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment in Middle-aged AdultsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Dr MOSNIER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149742
- Sponsor's protocol ID
- APHP210439
- Acronym
- SURDICOG
- Status last verified
- Jun 2025
- First submitted
- 28 Oct 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be collected and analysed into the GH Pitié-Salpêtrière (AP-HP)
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
- ClinicalTrials.gov ID
- NCT05149742
- Acronym / sponsor ID
- SURDICOG / APHP210439
- Keywords
- Severe and profound hearing loss, mild cognitive impairment (MCI), middle aged adult, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 24 May 2027 (estimated)
- Study completion
- 24 May 2027 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: Patients with severe to profound hearing loss | Experimental | Behavioral: Cognitive and audiometry evaluationPatients 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 |
| Controls: 90 matched subjects with normal hearing | Active comparator | Behavioral: Cognitive and audiometry evaluationHealthy controls aged between 45 to 64 years with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and audiometry evaluationFor both Patients and controls: * Cognitive functions evaluation * Tonal and vocal audiometry * Self questionnaires | Behavioural | Cases: Patients with severe to profound hearing loss, Controls: 90 matched subjects with normal hearing |
Primary outcome
Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing
Time frame: 1 day
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
Time frame: 1 day
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
Time frame: 1 day
"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
Time frame: 1 day
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
Time frame: 1 day
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
Time frame: 1 day
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
Time frame: 1 day
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.
2 secondary outcomes
Type of MCI
Time frame: 1 day
Impact of the severity of the hearing loss on presence and severity of cognitive disorders
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. All data will be collected and analysed into the GH Pitié-Salpêtrière (AP-HP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Dr MOSNIER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and audiometry evaluation in people with Mild Cognitive Impairment in Middle-aged Adults, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dr MOSNIER, MD (142162612 ext. +33, isabelle.mosnier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.