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Clinical Trials/NCT05706051
NCT05706051
Completed
Not Applicable

Modification de la Posture et Appareillage Auditif Dans la Presbyacousie

University Hospital, Angers2 sites in 1 country51 target enrollmentStarted: June 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University Hospital, Angers
Enrollment
51
Locations
2
Primary Endpoint
Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Masking Description

Ech individual is its proper control

Eligibility Criteria

Ages
55 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • the severity of the initial hearing loss(3 months)
  • the notion of a balance disorder described by the patient(3 months)
  • the effective wearing time of the device since its installation(3 months)

Investigators

Sponsor
University Hospital, Angers
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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