Clinical trial NCT05331404: Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
Official title: Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Keywords: Presbycusis
Auditory cortex.
Auditory plasticity.
Localization
Speech-in-noise
PET
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient and control
Primary purpose: BASIC_SCIENCE

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.

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:

* 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

Primary outcomes:
measure: level of brain activity
timeFrame: Month 12
Secondary outcomes:
measure: Life quality by Speech, Spatial and Qualities of Hearing (12)
timeFrame: Month 12
measure: Life quality by Speech, Spatial and Qualities of Hearing (6)
timeFrame: Month 6
measure: life quality by Hearing Handicap Inventory For The Elderly Screening (12)
timeFrame: Month 12
measure: life quality by Hearing Handicap Inventory For The Elderly Screening (6)
timeFrame: Month 6
measure: life quality by Short Form Health Survey (12)
timeFrame: Month 12
measure: life quality by Short Form Health Survey (6)
timeFrame: Month 6
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Mathieu MARX, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Visual activity predicts auditory recovery from deafness after adult cochlear implantation. Brain. 2013 Dec;136(Pt 12):3682-95. doi: 10.1093/brain/awt274. Epub 2013 Oct 17.
citation: Vannson N, James C, Fraysse B, Strelnikov K, Barone P, Deguine O, Marx M. Quality of life and auditory performance in adults with asymmetric hearing loss. Audiol Neurootol. 2015;20 Suppl 1:38-43. doi: 10.1159/000380746. Epub 2015 May 19.
citation: Vannson N, James CJ, Fraysse B, Lescure B, Strelnikov K, Deguine O, Barone P, Marx M. Speech-in-noise perception in unilateral hearing loss: Relation to pure-tone thresholds and brainstem plasticity. Neuropsychologia. 2017 Jul 28;102:135-143. doi: 10.1016/j.neuropsychologia.2017.06.013. Epub 2017 Jun 13.