NCT06183450

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Jan 2024Jan 2033

First Submitted

Initial submission to the registry

December 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

9 years

First QC Date

December 6, 2023

Last Update Submit

December 13, 2023

Conditions

Keywords

presbycusisagingcognitive declinespeech in noisesound localisationhearing loss

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Study Arms (1)

hearing subject

Adult normal hearing subjects, evaluated annually for 5 years,

Diagnostic Test: auditory levelDiagnostic Test: cognitive levelDiagnostic Test: quality of life level

Interventions

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.

hearing subject
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.

hearing subject
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.

hearing subject

Eligibility Criteria

Age45 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult normal hearing subjects aged between 45 and 50 years old.

You may qualify if:

  • Normal hearing (Pure Tone Audiometry \< or = 20 dB)
  • Residency in one of the three neighborhoods :
  • Affiliation with a social security system

You may not qualify if:

  • Individuals under guardianship, trusteeship or curators
  • History of neurological pathologies
  • Taking of psychotropic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ecole d'audioprothèse

Cahors, France

Location

MeSH Terms

Conditions

PresbycusisCognitive DysfunctionHearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Mathieu Marx, Pr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam ALZAHER, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 27, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

January 1, 2033

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations