Hearing LossAGEHEARNCT05331404
Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
A study testing PET examination and Quality of life assessment in people with Hearing Loss, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- PET examination and Quality of life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Toulouse
Toulouse, 31059
Mathieu MARX, PU-PH, 05 61 77 77 04 ext. +33, marx.m@chu-toulouse.fr
Mathieu MARX, PU-PH
About this study
Official title: Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- PET examination, Quality of life assessment
- Keywords
- Presbycusis, Auditory cortex., Auditory plasticity., Localization, Speech-in-noise, PET
- Medical subject headings
- Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET examinationRadiation
PET examinations with auditory stimuli such as human voice and environmental sounds.
Quality of life assessmentOther
quality of life assessment by :
- Speech, Spatial and Qualities of Hearing
- Hearing Handicap Inventory For The Elderly Screening
- Short Form Health Survey
| Study group | Role | What they receive |
|---|---|---|
| Presbycusis | Experimental | Patients with presbycusis who receive rehabilitation with hearing aids Receives: Radiation: PET examination; Other: Quality of life assessment |
| Aged control group | Active comparator | Aged control group: 15 subjects with normal or near-normal hearing thresholds Receives: Other: Quality of life assessment |
| Young control group | Active comparator | Young control group: 15 subjects with normal hearing thresholds Receives: Radiation: PET examination; Other: Quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 12
Secondary outcomes (6)
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).
Measured: Month 12
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).
Measured: Month 6
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).
Measured: Month 12
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).
Measured: Month 6
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.
Measured: Month 12
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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start2 Jun 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patient and control
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu MARX, Professor, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331404
- Sponsor's protocol ID
- RC31/20/0365
- Other IDs
- 2021-A01993-38
- Acronym
- AGEHEAR
- Status last verified
- Jun 2022
- First submitted
- 11 Apr 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24136826Vannson 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.
PubMed 25997394Vannson 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.
PubMed 28623107
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.
- ClinicalTrials.gov ID
- NCT05331404
- Acronym / sponsor ID
- AGEHEAR / RC31/20/0365
- Conditions
- Hearing Loss
- Keywords
- Presbycusis, Auditory cortex., Auditory plasticity., Localization, Speech-in-noise, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patient and control
| Arm | Type | Receives |
|---|---|---|
| Presbycusis | Experimental | Radiation: PET examination, Other: Quality of life assessmentPatients with presbycusis who receive rehabilitation with hearing aids |
| Aged control group | Active comparator | Other: Quality of life assessmentAged control group: 15 subjects with normal or near-normal hearing thresholds |
| Young control group | Active comparator | Radiation: PET examination, Other: Quality of life assessmentYoung control group: 15 subjects with normal hearing thresholds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Subjects matched in age (+/- 2 years) and gender with the presbycusis group
- Affiliation to a social security scheme or equivalent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET examinationPET examinations with auditory stimuli such as human voice and environmental sounds. | Radiation | Presbycusis, Young control group |
| Quality of life assessmentquality of life assessment by : * Speech, Spatial and Qualities of Hearing * Hearing Handicap Inventory For The Elderly Screening * Short Form Health Survey | Other | Aged control group, Presbycusis, Young control group |
Primary outcome
level of brain activity
Time frame: Month 12
level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task
6 secondary outcomes
Life quality by Speech, Spatial and Qualities of Hearing (12)
Time frame: Month 12
Life quality by Speech, Spatial and Qualities of Hearing (6)
Time frame: Month 6
life quality by Hearing Handicap Inventory For The Elderly Screening (12)
Time frame: Month 12
life quality by Hearing Handicap Inventory For The Elderly Screening (6)
Time frame: Month 6
life quality by Short Form Health Survey (12)
Time frame: Month 12
life quality by Short Form Health Survey (6)
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Background: PubMed 24136826Strelnikov 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.
- Background: PubMed 25997394Vannson 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.
- Background: PubMed 28623107Vannson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu MARX, Professor principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET examination and Quality of life assessment in people with Hearing Loss, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu MARX, Professor (05 61 77 77 04 ext. +33, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of brain activity (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05331404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.