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

June 28, 2022 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Presbycusis
Patients with presbycusis who receive rehabilitation with hearing aids
Radiation: PET examination
PET examinations with auditory stimuli such as human voice and environmental sounds.
Other: 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
Active Comparator: Aged control group
Aged control group: 15 subjects with normal or near-normal hearing thresholds
Other: 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
Active Comparator: Young control group
Young control group: 15 subjects with normal hearing thresholds
Radiation: PET examination
PET examinations with auditory stimuli such as human voice and environmental sounds.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life quality by Speech, Spatial and Qualities of Hearing (12)
Time Frame: Month 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).
Month 12
Life quality by Speech, Spatial and Qualities of Hearing (6)
Time Frame: Month 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).
Month 6
life quality by Hearing Handicap Inventory For The Elderly Screening (12)
Time Frame: Month 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).
Month 12
life quality by Hearing Handicap Inventory For The Elderly Screening (6)
Time Frame: Month 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).
Month 6
life quality by Short Form Health Survey (12)
Time Frame: Month 12
Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
Month 12
life quality by Short Form Health Survey (6)
Time Frame: Month 6
Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Mathieu MARX, Professor, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0365
  • 2021-A01993-38 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss

Clinical Trials on PET examination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe