Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Prevalence of sleep disorders
研究概览
简要总结
People living with HIV (PLHIV) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. The latest French multi-center epidemiological data are dated. The prevalence of the different types of sleep disorders, however, is poorly documented, with the literature focusing mainly on insomnia and neuropsychological disorders that can lead to sleep disorder-like symptoms, and on the impact of antiretroviral drugs in particular. However, there are other sleep disorders such as sleep apnea syndrome (SAHOS) or restless legs syndrome. SAHOS has been studied in small series of patients.
This multicenter, cross-sectional study will identify and update the functional complaints presented by PLHIV, estimate the prevalence of people at high risk of sleep apnea syndrome, and study the associated socio-demographic factors, in relation to HIV infection and antiretrovirals. This study could open up avenues for new management approaches and earlier detection of sleep disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PLHIV usually treated at referral centers in northern France.
排除标准
- •Minor patient;
- •Patient with insufficient understanding of the French language, as judged by the investigator;
- •Patient unable to give free and informed consent;
- •Refusal to participate;
- •Patient under legal protection, guardianship or curatorship;
- •Pregnant and breast-feeding women.
结局指标
主要结局
Prevalence of sleep disorders
时间窗: at baseline
The presence of sleep disorders will be defined according to the results of the Pittsburg Sleep Quality Index (PSQI), with a value greater than 5 defining the presence of sleep disorders.
次要结局
- Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome(at baseline)
- Prevalence of Restless Legs Syndrome(at baseline)