Back to resultsPostural Modification and Hearing Aids in Presbycusis (Post-AP)
Primary Purpose
Age-Related Hearing Loss, Postural; Defect, Hearing Aid
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
posturography
Sponsored by
About this trial
This is an interventional other trial for Age-Related Hearing Loss focused on measuring Age-related hearing loss, presbycusis, posture, Hearing Aid
Eligibility Criteria
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
Sites / Locations
- UH Angers
- Dr Lorin's otholaryngology practice
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
age-related hearing loss affected before hearing aid fitting
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the effective wearing time of the device since its installation
average of time within hearing aid use per day (on the last 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
the notion of a balance disorder described by the patient
vertigo or feeling of instability
Full Information
NCT ID
NCT05706051
First Posted
December 5, 2022
Last Updated
January 20, 2023
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT05706051
Brief Title
Postural Modification and Hearing Aids in Presbycusis
Acronym
Post-AP
Official Title
Modification de la Posture et Appareillage Auditif Dans la Presbyacousie
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Hearing Loss, Postural; Defect, Hearing Aid
Keywords
Age-related hearing loss, presbycusis, posture, Hearing Aid
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
Ech individual is its proper control
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
age-related hearing loss affected before hearing aid fitting
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
posturography
Intervention Description
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 Outcome Measure Information:
Title
Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients
Description
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 Outcome Measure Information:
Title
the effective wearing time of the device since its installation
Description
average of time within hearing aid use per day (on the last 3 months)
Time Frame
3 months
Title
the severity of the initial hearing loss
Description
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
Title
the notion of a balance disorder described by the patient
Description
vertigo or feeling of instability
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Boucher, M.D., Ph.D.
Phone
+33241353969
Email
sophie.boucher@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Boucher, M.D., Ph.D.
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie BOUCHER
Facility Name
Dr Lorin's otholaryngology practice
City
Le Mans
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe LORIN
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
anonimized data within elliptic surface of posturography, PTA, and self reported dissiness
Learn more about this trial
Postural Modification and Hearing Aids in Presbycusis
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