NCT05706051

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

December 5, 2022

Last Update Submit

August 11, 2025

Conditions

Age-Related Hearing LossPostural; DefectHearing Aid

Keywords

Age-related hearing losspresbycusispostureHearing Aid

Outcome Measures

Primary Outcomes (1)

  • Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients

    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 Outcomes (3)

  • the effective wearing time of the device since its installation

    3 months

  • the severity of the initial hearing loss

    3 months

  • the notion of a balance disorder described by the patient

    3 months

Study Arms (1)

age-related hearing loss affected before hearing aid fitting

OTHER

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

Interventions

posturographyOTHER

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

age-related hearing loss affected before hearing aid fitting

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UH Angers

Angers, France

Location

Dr Lorin's otholaryngology practice

Le Mans, France

Location

MeSH Terms

Conditions

Presbycusis

Interventions

Cytidine Diphosphate

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Sophie Boucher, M.D., Ph.D.

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Ech individual is its proper control
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

January 31, 2023

Study Start

June 1, 2023

Primary Completion

January 17, 2025

Study Completion

January 17, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations

FR(2)