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.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ile De France
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Paris、Ile De France、法国、75019
- Fondation Ophtalmologique Adolphe de Rothschild
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：横截面
队列和干预
团体/队列 |
|---|
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Patients
HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy
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Control
non-HIV (matched for age and gender)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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hearing loss at several frequencies
大体时间：Baseline
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Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
threshold for speech intelligibility
大体时间：Baseline
|
measured by speech audiometry
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Baseline
|
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Proportion of patients with neuropathic hearing loss
大体时间：Baseline
|
Baseline
|
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Interval I-V on the evoked-response audiogram
大体时间：Baseline
|
Baseline
|
|
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Maximum speech intelligibility
大体时间：Baseline
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Measured by speech audiometry
|
Baseline
|
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Proportion of patients with age-related hearing loss
大体时间：Baseline
|
Baseline
|
合作者和调查者
调查人员
- 首席研究员：Antoine Moulignier, MD、Fondation Ophtalmologique Antoine de Rothschild
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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