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Completed

NCT Number: NCT05706051

Postural Modification and Hearing Aids in Presbycusis

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 .

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

posturography

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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. the notion of a balance disorder described by the patient

    Time frame: 3 months

    vertigo or feeling of instability

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Modification de la Posture et Appareillage Auditif Dans la Presbyacousie

Acronym: Post-AP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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