Age-Related Hearing LossPost-APNCT05706051
Postural Modification and Hearing Aids in Presbycusis
A study testing posturography in people with Age-Related Hearing Loss and Postural; Defect, run by University Hospital, Angers at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Age-Related Hearing Loss, Postural; Defect, Hearing Aid
- What is being tested?
- posturography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2023to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- acute affliction that could affect the posturography test
- daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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 .
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.
- Conditions
- Age-Related Hearing Loss, Postural; Defect, Hearing Aid
- Being tested
- posturography
- Keywords
- Age-related hearing loss, presbycusis, posture, Hearing Aid
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: posturography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
the effective wearing time of the device since its installation
average of time within hearing aid use per day (on the last 3 months)
Measured: 3 months
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
Measured: 3 months
the notion of a balance disorder described by the patient
vertigo or feeling of instability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jun 2023
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sophie Boucher, M.D., Ph.D., Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706051
- Sponsor's protocol ID
- 2022-A02002-41
- Acronym
- Post-AP
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonimized data within elliptic surface of posturography, PTA, and self reported dissiness
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification de la Posture et Appareillage Auditif Dans la Presbyacousie
- ClinicalTrials.gov ID
- NCT05706051
- Acronym / sponsor ID
- Post-AP / 2022-A02002-41
- Conditions
- Age-Related Hearing Loss, Postural; Defect, Hearing Aid
- Keywords
- Age-related hearing loss, presbycusis, posture, Hearing Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| age-related hearing loss affected before hearing aid fitting | Other | Other: posturographypatients 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 55 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
Key exclusion criteria (2 listed)
- acute affliction that could affect the posturography test
- daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posturographyposturography 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 | Other | age-related hearing loss affected before hearing aid fitting |
Primary outcome
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 secondary outcomes
the effective wearing time of the device since its installation
Time frame: 3 months
the severity of the initial hearing loss
Time frame: 3 months
the notion of a balance disorder described by the patient
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided. anonimized data within elliptic surface of posturography, PTA, and self reported dissiness
Related trials for Age-Related Hearing Loss
Not yet recruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Sensorineural Hearing Loss, Presbyacusis
Not yet recruitingObservational study
Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
Hearing Loss, Age-Related, Presbycusis
Active, not recruiting
Hearing Healthcare Assessment in Rural Communities
Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
Recruiting
Early Age-Related Hearing Loss Investigation (EARHLI)
Alzheimer Disease, Hearing Loss
Not yet recruiting
HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship
Hearing Loss, Hearing Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Boucher, M.D., Ph.D. principal investigator
University Hospital, Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posturography in people with Age-Related Hearing Loss and Postural; Defect, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.