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NCT Number: NCT02154971

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. hearing loss at several frequencies

    Time frame: Baseline

    Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.

Secondary outcomes

  1. threshold for speech intelligibility

    Time frame: Baseline

    measured by speech audiometry

  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

    Time frame: Baseline

    Measured by speech audiometry

  5. Proportion of patients with age-related hearing loss

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: HELO

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2014
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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