Assessment of Age-related Hearing Loss in HIV-1 Patients

Completed

• Conditions: HIV Seropositivity

• Registration Number: NCT02154971
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

The ageing process is known to be accelerated in HIV-infected patients, compared to the general population.

Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial damage caused by oxidative stress.

Risk factors for accelerated age-related hearing loss are present in many HIV-infected patients : chronic inflammation, smoking, diabetes, etc.

The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive population in France, and to compare it to HIV negative controls matched for age and sex.

90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a screening for presbyacusia (pure-tone, speech and evoked-response audiometry).

We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as compared to controls matched for age and sex.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2019-02-26
• Study Completion: 2019-02-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Age 40 years and more
• HIV-1 infection known since 10 years and more
• Undetectable plasmatic HIV-1 viral load thanks to antiretroviral therapy (any regimen) for at least 5 years
• CD4 lymphocytes count above 350
• Condition of Cerebral Small Vessel Disease detected recently with MRI

Exclusion Criteria

• Personal history of otologic pathology or otologic surgery
• Family history of hearing impairment
• Personal history of bacterial meningitis
• Personal history of neurological disease
• Personal history of treatment with ototoxic drugs
• Personal history of treatment with chemotherapy
• Use of illegal drugs (except cannabis or poppers)
• Alcoholism
• Diabetes complicated by retinopathy and/or by glomerular filtration rate < 60 mL/min and/or by proteinuria > 300 mg)
• Uncontrolled high blood pressure (WHO criteria)
• MRI contraindication
• Known pregnancy or breastfeeding woman
• No medical insurance coverage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hearing loss at several frequencies	Baseline	Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.

Secondary Outcome Measures

Name	Time	Method
threshold for speech intelligibility	Baseline	measured by speech audiometry
Proportion of patients with neuropathic hearing loss	Baseline
Interval I-V on the evoked-response audiogram	Baseline
Maximum speech intelligibility	Baseline	Measured by speech audiometry
Proportion of patients with age-related hearing loss	Baseline

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, Ile De France, France