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

NCT ID: NCT05331404

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patient and control
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Presbycusis

Patients with presbycusis who receive rehabilitation with hearing aids

Group Type EXPERIMENTAL

PET examination

Intervention Type RADIATION

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

Quality of life assessment

Intervention Type OTHER

quality of life assessment by :

* Speech, Spatial and Qualities of Hearing
* Hearing Handicap Inventory For The Elderly Screening
* Short Form Health Survey

Aged control group

Aged control group: 15 subjects with normal or near-normal hearing thresholds

Group Type ACTIVE_COMPARATOR

Quality of life assessment

Intervention Type OTHER

quality of life assessment by :

* Speech, Spatial and Qualities of Hearing
* Hearing Handicap Inventory For The Elderly Screening
* Short Form Health Survey

Young control group

Young control group: 15 subjects with normal hearing thresholds

Group Type ACTIVE_COMPARATOR

PET examination

Intervention Type RADIATION

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

Quality of life assessment

Intervention Type OTHER

quality of life assessment by :

* Speech, Spatial and Qualities of Hearing
* Hearing Handicap Inventory For The Elderly Screening
* Short Form Health Survey

Interventions

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PET examination

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

Intervention Type RADIATION

Quality 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu MARX, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathieu MARX, Professor

Role: CONTACT

05 61 77 77 04 ext. +33

Facility Contacts

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Mathieu MARX, PU-PH

Role: primary

05 61 77 77 04 ext. +33

References

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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.

Reference Type BACKGROUND
PMID: 24136826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25997394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28623107 (View on PubMed)

Other Identifiers

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2021-A01993-38

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/20/0365

Identifier Type: -

Identifier Source: org_study_id

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