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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT02154971

Collaborator

(none)

206

Enrollment

Location

63.3

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositivity

Study Design

Study Type:

Observational

Actual Enrollment :

206 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 18, 2013

Actual Primary Completion Date :

Feb 26, 2019

Actual Study Completion Date :

Feb 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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