Postural Modification and Hearing Aids in Presbycusis

Not Applicable

Not yet recruiting

• Conditions: Postural; Defect; Hearing Aid; Age-Related Hearing Loss
• Interventions: Other: posturography

• Registration Number: NCT05706051
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study First Submitted: 2022-12-05
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Study Start: 2023-02-02
• Primary Completion: 2024-06
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
age-related hearing loss affected before hearing aid fitting	posturography	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

UH Angers; 🇫🇷 Angers, France

Dr Lorin's otholaryngology practice; 🇫🇷 Le Mans, France