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CompletedNCT02154971HELOUpdated Sep 16, 2020

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

An observational study in HIV Seropositivity, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
206
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Seropositivity

Keywords

  • HIV Seropositivity
  • Audiometry
  • Hearing Loss
03

In context

HIV Seropositivity

210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.

This study's enrollment of 206 is close to the median of 223 across 62 observational studies indexed under HIV Seropositivity.

Browse HIV Seropositivity studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
206 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

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

  • Control

    non-HIV (matched for age and gender)

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. threshold for speech intelligibility

    measured by speech audiometry

    Time frame: Baseline

  2. Proportion of patients with neuropathic hearing loss

    Time frame: Baseline

  3. Interval I-V on the evoked-response audiogram

    Time frame: Baseline

  4. Maximum speech intelligibility

    Measured by speech audiometry

    Time frame: Baseline

  5. Proportion of patients with age-related hearing loss

    Time frame: Baseline

07

Study locations

1 site
  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, Ile De France 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02154971
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Jun 4, 2014
Start date
Nov 18, 2013
Primary completion
Feb 26, 2019
Completion
Feb 26, 2019
Last update
Sep 16, 2020

Study contacts

Antoine Moulignier, MD
principal investigator · Fondation Ophtalmologique Antoine de Rothschild

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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