PresbycusisACAVNCT06183450
Hearing and Cognition in Aging Adults
An observational study of Presbycusis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders Read more about this study
- Who is it for?
- Ages 45 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbycusis
- What is being tested?
- auditory level, cognitive level and quality of life level
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2024to Jan 2033
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult normal hearing subjects aged between 45 and 50 years old.
Who may be able to join
- Normal hearing (Pure Tone Audiometry < or = 20 dB)
- Residency in one of the three neighborhoods :
- Affiliation with a social security system
Who cannot join
- Individuals under guardianship, trusteeship or curators
- History of neurological pathologies
- Taking of psychotropic medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mariam ALZAHER, Dr contact
About this study
This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders
Read the detailed description
The aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. This project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. The data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.
- Conditions
- Presbycusis
- Being tested
- auditory level, cognitive level, quality of life level
- Keywords
- presbycusis, aging, cognitive decline, speech in noise, sound localisation, hearing loss
- Medical subject headings
- Presbycusis, Cognitive Dysfunction, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auditory levelDiagnostic test
- Evaluation of auditory thresholds through audiometric tests.
- Evaluation of speech comprehension in noise through a vocal audiometry test in noise (FraMatrix).
- Evaluation of spatial auditory behavior and spatial precision using a spatial discrimination test (Minimum Audible Angle) and a static sound localization test in virtual reality.
cognitive levelDiagnostic test
- Evaluation of attention and short-term memory functions with verbal and non-verbal tasks: Digit Span Test and Reading Span Test.
- Evaluation of inhibition capacities using the Stroop Test.
- Evaluation of executive functions, visual attention, reasoning, and mental arithmetic using the Raven's Matrix test.
quality of life levelDiagnostic test
- Evaluation of quality of live level via Speech, Spatial and Qualities of Hearing Scale (SSQ-12) and EuroQol-5D questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| hearing subject | Adult normal hearing subjects, evaluated annually for 5 years, Receives: Diagnostic Test: auditory level; Diagnostic Test: cognitive level; Diagnostic Test: quality of life level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure-ton audiometry
Pure-tone audiometry will be evaluated by collecting the threshold in air and bone conduction for both ears on each frequency tested (125-250-500-1000-2000-4000 and 8000 Hz), as well as the average hearing loss (MAP ) on all five frequencies.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2033 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbycusisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Marx, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183450
- Sponsor's protocol ID
- RC31/22/0252
- Other IDs
- 2023-A01415-40
- Acronym
- ACAV
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing and Cognition in Aging Adults
- ClinicalTrials.gov ID
- NCT06183450
- Acronym / sponsor ID
- ACAV / RC31/22/0252
- Conditions
- Presbycusis
- Keywords
- presbycusis, aging, cognitive decline, speech in noise, sound localisation, hearing loss
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 27 Dec 2023 (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.
This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders
Detailed description
The aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. This project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. The data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hearing subject | – | Diagnostic Test: auditory level, Diagnostic Test: cognitive level, Diagnostic Test: quality of life levelAdult normal hearing subjects, evaluated annually for 5 years, |
Who may qualify
- Ages
- 45 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult normal hearing subjects aged between 45 and 50 years old.
Key inclusion criteria (3 listed)
- Normal hearing (Pure Tone Audiometry < or = 20 dB)
- Residency in one of the three neighborhoods :
- Affiliation with a social security system
Key exclusion criteria (3 listed)
- Individuals under guardianship, trusteeship or curators
- History of neurological pathologies
- Taking of psychotropic medication.
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 |
|---|---|---|
| auditory level* Evaluation of auditory thresholds through audiometric tests. * Evaluation of speech comprehension in noise through a vocal audiometry test in noise (FraMatrix). * Evaluation of spatial auditory behavior and spatial precision using a spatial discrimination test (Minimum Audible Angle) and a static sound localization test in virtual reality. | Diagnostic test | hearing subject |
| cognitive level* Evaluation of attention and short-term memory functions with verbal and non-verbal tasks: Digit Span Test and Reading Span Test. * Evaluation of inhibition capacities using the Stroop Test. * Evaluation of executive functions, visual attention, reasoning, and mental arithmetic using the Raven's Matrix test. | Diagnostic test | hearing subject |
| quality of life level- Evaluation of quality of live level via Speech, Spatial and Qualities of Hearing Scale (SSQ-12) and EuroQol-5D questionnaires. | Diagnostic test | hearing subject |
Primary outcome
Pure-ton audiometry
Time frame: 5 years
Pure-tone audiometry will be evaluated by collecting the threshold in air and bone conduction for both ears on each frequency tested (125-250-500-1000-2000-4000 and 8000 Hz), as well as the average hearing loss (MAP ) on all five frequencies.
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 27 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Mariam ALZAHER, Dr contact
Mathieu Marx, Pr principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbycusis, run by University Hospital, Toulouse 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Dec 2023. 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 Mathieu Marx, Pr (05 61 77 77 04 ext. +33, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure-ton audiometry (time frame: 5 years). 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 27 Dec 2023.