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Clinical Trials/NCT05331404
NCT05331404
Unknown
N/A

Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.

University Hospital, Toulouse1 site in 1 country45 target enrollmentJune 2, 2022
ConditionsHearing Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
University Hospital, Toulouse
Enrollment
45
Locations
1
Primary Endpoint
level of brain activity
Last Updated
3 years ago

Overview

Brief Summary

Hearing aids restore efficiently some auditory functions in age-related hearing loss (ARHL or presbycusis) providing to the elderly an access to oral communication and a return to social life. However, a most of the assessments of their efficacy focus on speech recognition. Spatial hearing and localization are anothers important auditory functions merely evaluated.

The purpose of this study is to evaluate the hearing aids benefits for spatial hearing.

Detailed Description

The main objective is to evaluate the hearing aids benefits for spatial hearing with a multidisciplinary approach combing psychophysics, and Positron Emission Tomography (PET) brain imaging in a before/after experimental design. The novelty of the proposal is both theoretical and methodological: the team aim is to identify neural correlates of spatial hearing after hearing rehabilitation and evaluate the evolution of spatial hearing abilities once subjects with presbycusis are fitted with hearing aids. The assessment of spatial hearing processing will rely on both a virtual visuo-auditory 3D immersive platform and functional neuroimaging using PET scan. This project will provide crucial elements for understanding and improving the rehabilitation of age-related hearing loss.

Registry
clinicaltrials.gov
Start Date
June 2, 2022
End Date
April 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For presbyacusics subjects:
  • Subjects aged over 50 with a difference in symmetrical audiometric thresholds (\< 15 dB) between the two ears and requiring hearing aids
  • Affiliation to a social security scheme or equivalent
  • Acceptance of the protocol and signature of the consent form
  • For older people with normal hearing:
  • Subjects matched in age (+/- 2 years) and gender with the presbycusis group
  • Affiliation to a social security scheme or equivalent
  • Acceptance of the protocol and signature of the consent form
  • Subjects with normal hearing, with hearing thresholds of 20 dB \< 2kHz and 40 dB \< 4kHz
  • For young people with normal hearing:

Exclusion Criteria

  • Persons under a legal protection regime for adults (safeguard of justice, guardianship, curator ship, institutionalized, or under mandate for future protection)
  • History of associated neurological pathology
  • Contraindications to PET
  • Cognitive impairment confirmed by the Montreal Cognitive Assessment (MOCA) test (for presbyacusic subjects and normal-hearing elderly subjects)
  • Taking psychotropic drugs
  • History of epilepsy
  • Pregnant or breastfeeding woman
  • Participation in another intervention protocol

Outcomes

Primary Outcomes

level of brain activity

Time Frame: Month 12

level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task

Secondary Outcomes

  • life quality by Hearing Handicap Inventory For The Elderly Screening (12)(Month 12)
  • life quality by Hearing Handicap Inventory For The Elderly Screening (6)(Month 6)
  • Life quality by Speech, Spatial and Qualities of Hearing (6)(Month 6)
  • Life quality by Speech, Spatial and Qualities of Hearing (12)(Month 12)
  • life quality by Short Form Health Survey (12)(Month 12)
  • life quality by Short Form Health Survey (6)(Month 6)

Study Sites (1)

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