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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02154971

Acronym

HELO

Enrollment

206

Registered

2014-06-04

Start date

2013-11-18

Completion date

2019-02-26

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Seropositivity

Keywords

HIV Seropositivity, Audiometry, Hearing Loss

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

France

Outcome results