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CompletedNCT05706051Post-APUpdated Aug 14, 2025

Postural Modification and Hearing Aids in Presbycusis

An interventional study of posturography in Age-Related Hearing Loss, Postural; Defect and Hearing Aid, sponsored by University Hospital, Angers. Completed at 2 sites in France. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
55 Years to 80 Years
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Age-Related Hearing Loss
  • Postural; Defect
  • Hearing Aid

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Keywords

  • Age-related hearing loss
  • presbycusis
  • posture
  • Hearing Aid
03

In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's enrollment of 51 is below the median of 60 across 45 interventional studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • acute affliction that could affect the posturography test
  • daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • 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

Interventions

  • Otherposturography

    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

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. the effective wearing time of the device since its installation

    average of time within hearing aid use per day (on the last 3 months)

    Time frame: 3 months

  2. the severity of the initial hearing loss

    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

    Time frame: 3 months

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

    vertigo or feeling of instability

    Time frame: 3 months

07

Study locations

2 sites
  • UH Angers
    Angers, France
  • Dr Lorin's otholaryngology practice
    Le Mans, France
08

References and documents

Individual participant data

Plan to share: Undecided — anonimized data within elliptic surface of posturography, PTA, and self reported dissiness

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Jan 2025, 19 months.

Of 25 interventional studies with no phase under Presbycusis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2022
First posted
Jan 31, 2023
StartActual
Jun 1, 2023
Primary completionActual
Jan 17, 2025
CompletionActual
Jan 17, 2025
Last update
Aug 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05706051
Responsible party
Sponsor
First posted
Jan 31, 2023
Start date
Jun 1, 2023
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025
Last update
Aug 14, 2025

Study contacts

Sophie Boucher, M.D., Ph.D.
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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