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Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05331404
Acronym
AGEHEAR
Enrollment
45
Registered
2022-04-15
Start date
2022-06-02
Completion date
2024-04-30
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Presbycusis, Auditory cortex., Auditory plasticity., Localization, Speech-in-noise, PET

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.

Interventions

PET examinations with auditory stimuli such as human voice and environmental sounds.

OTHERQuality of life assessment

quality of life assessment by : * Speech, Spatial and Qualities of Hearing * Hearing Handicap Inventory For The Elderly Screening * Short Form Health Survey

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Patient and control

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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: * Subjects aged between 18 and 40 years old, * Symmetric normal hearing * Affiliation to a social security scheme or equivalent * Normally hearing subjects with audiometric thresholds \< 20 dB * Acceptance of the protocol and signature of the consent form

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

Design outcomes

Primary

MeasureTime frameDescription
level of brain activityMonth 12level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task

Secondary

MeasureTime frameDescription
Life quality by Speech, Spatial and Qualities of Hearing (6)Month 6Speech, Spatial and Qualities of Hearing is a questionnaire specific to the quality of hearing. It has 3 sections; speech hearing, spatial hearing and quality of hearing. This questionnaire contains 15 items evaluated on a scale to 0 (not at all) to 10 (perfectly).
life quality by Hearing Handicap Inventory For The Elderly Screening (12)Month 12Hearing Handicap Inventory For The Elderly Screening contains 10 items to identify the social and emotional difficulties encountered by the subject due to his deafness according to specific situations. It makes it possible to detect the handicap perceived by the person (the higher the score, the greater the perception of the handicap due to hearing loss).
Life quality by Speech, Spatial and Qualities of Hearing (12)Month 12Speech, Spatial and Qualities of Hearing is a questionnaire specific to the quality of hearing. It has 3 sections; speech hearing, spatial hearing and quality of hearing. This questionnaire contains 15 items evaluated on a scale to 0 (not at all) to 10 (perfectly).
life quality by Short Form Health Survey (12)Month 12Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
life quality by Short Form Health Survey (6)Month 6Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
life quality by Hearing Handicap Inventory For The Elderly Screening (6)Month 6Hearing Handicap Inventory For The Elderly Screening contains 10 items to identify the social and emotional difficulties encountered by the subject due to his deafness according to specific situations. It makes it possible to detect the handicap perceived by the person (the higher the score, the greater the perception of the handicap due to hearing loss).

Countries

France

Contacts

Primary ContactMathieu MARX, Professor
marx.m@chu-toulouse.fr05 61 77 77 04

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026