Assessment of Age-related Hearing Loss in HIV-1 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- hearing loss at several frequencies
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
hearing loss at several frequencies
时间窗: Baseline
Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.
次要结局
- 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)