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 Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Assessment of Age-related Hearing Loss in HIV-1 Patients|
- hearing loss at several frequencies [ Time Frame: Baseline ] [ Designated as safety issue: No ]Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.
- threshold for speech intelligibility [ Time Frame: Baseline ] [ Designated as safety issue: No ]measured by speech audiometry
- Proportion of patients with neuropathic hearing loss [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Interval I-V on the evoked-response audiogram [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Maximum speech intelligibility [ Time Frame: Baseline ] [ Designated as safety issue: No ]Measured by speech audiometry
- Proportion of patients with age-related hearing loss [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy
non-HIV (matched for age and gender)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02154971
|Contact: Antoine Moulignier, MD||+33 148 036 firstname.lastname@example.org|
|Fondation Ophtalmologique Adolphe de Rothschild||Recruiting|
|Paris, Ile de France, France, 75019|
|Principal Investigator:||Antoine Moulignier, MD||Fondation Ophtalmologique Antoine de Rothschild|