- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282601
STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS (AMORCAGE MUSIC)
Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.
However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.
In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.
This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline GUIGOU
- Phone Number: 03 80 29 37 58
- Email: caroline.guigou@chu-dijon.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No objection to participation in the study
- Men and women aged ≥ 70 years
- Patients diagnosed with presbyacusis (age-related bilateral and symmetrical sensorineural hearing loss, all stages combined), with or without the use of a bilateral hearing aid.
- If they use a hearing aid: hearing must have an average free-field fitted tonal threshold of 40 dB max and free-field fitted speech discrimination without lip-reading of 90-100% at 60dB in silence.
- MMSE score ≥ 24/30
Exclusion Criteria:
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Adult unable to provide consent
- Person with a neurocognitive disorder (post-stroke, dyslexia, dyspraxia) or neuro-psychiatric disorder (dementia, autism)
- Severe sensorineural hearing loss with mean free-field threshold > 40 dB and free-field speech discrimination without lip-reading of < 90-100% at 60dB in silence
- Asymmetrical sensorineural hearing loss due to an additional cause of hearing loss on one side.
Secondary exclusion criteria:
Person with syntax disorder (discovery of sentence comprehension or production disorders during syntax test)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Presbyacusis patients
|
Tonal and vocal free-field without lip-reading
Listening to music with a regular or irregular rhythm, then judging the grammaticality of 2x6 blocks of French sentences interrupted by a pause, each block presenting 4 sentences including 2 grammatically correct sentences and 2 grammatically incorrect sentences.
The sentences are pronounced by a French female voice at a natural rhythm and comfortable volume.
test to assess a person's cognitive functions and memory capacity.
20 questions exploring 5 main facets of the musical reward experience, with 4 items for each of the 5 facets, for which participants indicate the level of agreement using a 5-level scale, ranging from "strongly disagree" to "strongly agree".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
linguistic performance test focusing on syntax.
Time Frame: At baseline
|
At baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GUIGOU - Defaye 2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Audiogram
-
University of ZurichCompleted
-
National Center for Research Resources (NCRR)CompletedRetinitis Pigmentosa | Usher Syndrome | Congenital Hearing ImpairmentUnited States
-
Ministry of Health, MalaysiaCompleted
-
University of NottinghamNottingham University Hospitals NHS Trust; Birmingham Women's and Children's... and other collaboratorsUnknownCystic Fibrosis | Sensorineural Hearing LossUnited Kingdom
-
Oticon MedicalRecruitingEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
-
University Medical Center GroningenCompleted
-
HaEmek Medical Center, IsraelNot yet recruitingVitamin D Deficiency | Osteoporosis | Osteopenia | Vestibular Disorder | Meniere Disease
-
University of MiamiCompletedCervical CancerUnited States