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

NCT02154971 | Completed

• 1 other identifier: AMR_2013-10
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity

Keywords

HIV Seropositivity; Audiometry; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• threshold for speech intelligibility

  Baseline

• Proportion of patients with neuropathic hearing loss

  Baseline

• Interval I-V on the evoked-response audiogram

  Baseline

• Maximum speech intelligibility

  Baseline

• Proportion of patients with age-related hearing loss

  Baseline

Study Arms (2)

Patients

HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy

Control

non-HIV (matched for age and gender)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

HIV Seropositivity; Hearing Loss

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine Moulignier, MD

  Fondation Ophtalmologique Antoine de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: November 18, 2013
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

FR (1)