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

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.

Study Overview

• Status: Completed
• Conditions: HIV Seropositivity

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75019
      • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients followed for HIV infection in the department of infectious diseases of Saint-Antoine hospital or Bichat hospital and/or by a private HIV-specialized physician in Paris, France

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Antoine Moulignier, MD, Fondation Ophtalmologique Antoine de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2013
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: HIV Seropositivity; Audiometry; Hearing Loss
• Additional Relevant MeSH Terms: Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; HIV Infections; Hearing Disorders; Hearing Loss, Sensorineural; HIV Seropositivity; Hearing Loss; Deafness; Presbycusis
• Other Study ID Numbers: AMR_2013-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No