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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Seropositivity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy | |
| Control<br>non-HIV (matched for age and gender) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hearing loss at several frequencies | Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB. | Baseline | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Seropositivity, Audiometry, Hearing Loss