Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
AGEHEAR
Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJuly 5, 2022
June 1, 2022
1.8 years
April 11, 2022
June 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
level of brain activity
level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task
Month 12
Secondary Outcomes (6)
Life quality by Speech, Spatial and Qualities of Hearing (12)
Month 12
Life quality by Speech, Spatial and Qualities of Hearing (6)
Month 6
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 Short Form Health Survey (12)
Month 12
- +1 more secondary outcomes
Study Arms (3)
Presbycusis
EXPERIMENTALPatients with presbycusis who receive rehabilitation with hearing aids
Aged control group
ACTIVE COMPARATORAged control group: 15 subjects with normal or near-normal hearing thresholds
Young control group
ACTIVE COMPARATORYoung control group: 15 subjects with normal hearing thresholds
Interventions
PET examinations with auditory stimuli such as human voice and environmental sounds.
quality of life assessment by : * Speech, Spatial and Qualities of Hearing * Hearing Handicap Inventory For The Elderly Screening * Short Form Health Survey
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Toulouse
Toulouse, 31059, France
Related Publications (3)
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.
PMID: 24136826BACKGROUNDVannson 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.
PMID: 25997394BACKGROUNDVannson 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.
PMID: 28623107BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu MARX, Professor
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2022
First Posted
April 15, 2022
Study Start
June 2, 2022
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
July 5, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share