Postural Modification and Hearing Aids in Presbycusis

Postural; Defect Clinical Trial

— Post-AP  

Official title:

Modification de la Posture et Appareillage Auditif Dans la Presbyacousie

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05706051
• Other study ID #: 2022-A02002-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Angers
• Contact: Sophie Boucher, M.D., Ph.D.
• Phone: +33241353969
• Email: sophie.boucher[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Hospital ENT department and ENT Medical Doctor of Le Mans .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• posturography
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

Locations

Country	Name	City	State
France	UH Angers	Angers
France	Dr Lorin's otholaryngology practice	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the effective wearing time of the device since its installation	average of time within hearing aid use per day (on the last 3 months)	3 months
Secondary	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	3 months
Secondary	the notion of a balance disorder described by the patient	vertigo or feeling of instability	3 months