Postural Modification and Hearing Aids in Presbycusis (Post-AP)

August 11, 2025 updated by: University Hospital, Angers

Modification de la Posture et Appareillage Auditif Dans la Presbyacousie

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

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 Locations

  • France
      • Angers, France
        • UH Angers
      • Le Mans, France
        • Dr Lorin's otholaryngology practice

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

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effective wearing time of the device since its installation
Time Frame: 3 months
average of time within hearing aid use per day (on the last 3 months)
3 months
the severity of the initial hearing loss
Time Frame: 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
3 months
the notion of a balance disorder described by the patient
Time Frame: 3 months
vertigo or feeling of instability
3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Sophie Boucher, M.D., Ph.D., University Hospital, Angers

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 1, 2023

Primary Completion (Actual)

January 17, 2025

Study Completion (Actual)

January 17, 2025

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A02002-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

anonimized data within elliptic surface of posturography, PTA, and self reported dissiness

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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