Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population. (AGEHEAR)
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET examination
Quality of life assessment
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss focused on measuring Presbycusis, Auditory cortex., Auditory plasticity., Localization, Speech-in-noise, PET
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
Sites / Locations
- CHU ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Presbycusis
Aged control group
Young control group
Arm Description
Patients with presbycusis who receive rehabilitation with hearing aids
Aged control group: 15 subjects with normal or near-normal hearing thresholds
Young control group: 15 subjects with normal hearing thresholds
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Life quality by Speech, Spatial and Qualities of Hearing (12)
Speech, 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 Speech, Spatial and Qualities of Hearing (6)
Speech, 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)
Hearing 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 Hearing Handicap Inventory For The Elderly Screening (6)
Hearing 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 Short Form Health Survey (12)
Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
life quality by Short Form Health Survey (6)
Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
Full Information
NCT ID
NCT05331404
First Posted
April 11, 2022
Last Updated
June 28, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT05331404
Brief Title
Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
Acronym
AGEHEAR
Official Title
Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Presbycusis, Auditory cortex., Auditory plasticity., Localization, Speech-in-noise, PET
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient and control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Presbycusis
Arm Type
Experimental
Arm Description
Patients with presbycusis who receive rehabilitation with hearing aids
Arm Title
Aged control group
Arm Type
Active Comparator
Arm Description
Aged control group: 15 subjects with normal or near-normal hearing thresholds
Arm Title
Young control group
Arm Type
Active Comparator
Arm Description
Young control group: 15 subjects with normal hearing thresholds
Intervention Type
Radiation
Intervention Name(s)
PET examination
Intervention Description
PET examinations with auditory stimuli such as human voice and environmental sounds.
Intervention Type
Other
Intervention Name(s)
Quality of life assessment
Intervention Description
quality of life assessment by :
Speech, Spatial and Qualities of Hearing
Hearing Handicap Inventory For The Elderly Screening
Short Form Health Survey
Primary Outcome Measure Information:
Title
level of brain activity
Description
level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Life quality by Speech, Spatial and Qualities of Hearing (12)
Description
Speech, 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).
Time Frame
Month 12
Title
Life quality by Speech, Spatial and Qualities of Hearing (6)
Description
Speech, 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).
Time Frame
Month 6
Title
life quality by Hearing Handicap Inventory For The Elderly Screening (12)
Description
Hearing 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).
Time Frame
Month 12
Title
life quality by Hearing Handicap Inventory For The Elderly Screening (6)
Description
Hearing 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).
Time Frame
Month 6
Title
life quality by Short Form Health Survey (12)
Description
Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
Time Frame
Month 12
Title
life quality by Short Form Health Survey (6)
Description
Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu MARX, Professor
Phone
05 61 77 77 04
Ext
+33
Email
marx.m@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu MARX, Professor
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu MARX, PU-PH
Phone
05 61 77 77 04
Ext
+33
Email
marx.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Mathieu MARX, PU-PH
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24136826
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.
Results Reference
background
PubMed Identifier
25997394
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.
Results Reference
background
PubMed Identifier
28623107
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.
Results Reference
background
Learn more about this trial
Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
We'll reach out to this number within 24 hrs