Post-AP: Postural Modification and Hearing Aids in Presbycusis

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05706051

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Age-Related Hearing Loss Postural; Defect Hearing Aid	Other: posturography	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Masking Description:

Ech individual is its proper control

Primary Purpose:

Other

Official Title:

Modification de la Posture et Appareillage Auditif Dans la Presbyacousie

Anticipated Study Start Date :

Feb 2, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: age-related hearing loss affected before hearing aid fitting patients aged 55 to 80 years old, undergoing posturography at diagnosis of ARHL and 3 months later before hearing aid fitting, within the role of control same patients udergoing posturography at hearing aid fitting and 3 months after.	Other: posturography posturography will be performed when diagnosis of ARHL, in need of hearing aid fitting, is done and after information and written approval from patient. Posturography is performed later when hearing aid fitting and 3months after hearing aid use

Arm

Intervention/Treatment

Other: age-related hearing loss affected before hearing aid fitting

patients aged 55 to 80 years old, undergoing posturography at diagnosis of ARHL and 3 months later before hearing aid fitting, within the role of control same patients udergoing posturography at hearing aid fitting and 3 months after.

Other: posturography

posturography will be performed when diagnosis of ARHL, in need of hearing aid fitting, is done and after information and written approval from patient. Posturography is performed later when hearing aid fitting and 3months after hearing aid use

Outcome Measures

Primary Outcome Measures

Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients [3 months]
analysis of variation of elliptic surface (cm2), eyes opened and closed, and subsequent romberg quotient (elliptic surface closed eyes/elliptic surface opened eyes) in the 3 months before hearing aid fitting and the 3 months after

Secondary Outcome Measures

the effective wearing time of the device since its installation [3 months]
average of time within hearing aid use per day (on the last 3 months)
the severity of the initial hearing loss [3 months]
calculation of the average hearing loss measured by the average of the hearing thresholds without a hearing aid at 0.5, 1, 2 and 4 kHz
the notion of a balance disorder described by the patient [3 months]
vertigo or feeling of instability

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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