Clinical trial NCT05706051: Postural Modification and Hearing Aids in Presbycusis
Official title: Modification de la Posture et Appareillage Auditif Dans la Presbyacousie
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-Related Hearing Loss
Postural; Defect
Hearing Aid
Keywords: Age-related hearing loss
presbycusis
posture
Hearing Aid
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective study, with analysis of posturography parameters variation before and after hearing aid fitting in age-related hearing loss affected population aged 55 to 80 years old.
Primary purpose: OTHER

Brief summary: Presbycusis could be associated to increased risk to fall. There is little about the impact on postural balance of hearing aids. In this study, the investigators describe the postural balance evolution before and after hearing aid fitting in presbycusis-affected adults (55-80years old) consulting Angers University Hospital ENT department and ENT Medical Doctor of Le Mans .

Detailed description: After being informed about te study and consentment, patients meeting inclusion criteria consulting for presbycusis and in indication for hearing aids will be included to have posturometry (V0). Posturometry is performed 3 months later, before the first hearing aid installation (V1a) and after (V1b), as well as three months after hearing aid wearing (V2). Evolution of posturometry parameters without hearing aids between V0 and V1a serve as control and is compared to the evolution of posturometry parameters after hearing aid wearing between V1b and V2.

Eligibility criteria: Inclusion Criteria:

* 55 to 80 years old
* ARHL within PTA superior to 30dBHL, and intelligibility threshold 30dB or worse defining hearing aid fitting indication in France

Non inclusion Criteria:

* hearing aid fitting refusal or contrindication
* vestibulare rehabilitation in past 3 months
* unusual physical activity the day of the posturography test
* incapacity to understand the instruction, or to stand up the time of posturography without help
* predictable incapacity to perform posturography in the time of the study

Exclusion criteria:

* acute affliction that could affect the posturography test
* daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography

Primary outcomes:
measure: Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients
timeFrame: 3 months
Secondary outcomes:
measure: the effective wearing time of the device since its installation
timeFrame: 3 months
measure: the severity of the initial hearing loss
timeFrame: 3 months
measure: the notion of a balance disorder described by the patient
timeFrame: 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
city: Le Mans
country: France
facility: Dr Lorin's otholaryngology practice
Study officials:
affiliation: University Hospital, Angers
name: Sophie Boucher, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: