An interventional study of PET examination and Quality of life assessment in Hearing Loss, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science
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.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 45 is close to the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For presbyacusics subjects:
For older people with normal hearing:
For young people with normal hearing:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with presbycusis who receive rehabilitation with hearing aids
Radiation: PET examination · Other: Quality of life assessment
Aged control group: 15 subjects with normal or near-normal hearing thresholds
Other: Quality of life assessment
Young control group: 15 subjects with normal hearing thresholds
Radiation: PET examination · Other: Quality of life assessment
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
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
Time frame: Month 12
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Month 6
Plan to share: No
Started Jun 2022 (actual). Primary completion is estimated for Apr 2024, 22 months after the start.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 22 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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