HIV Infections Clinical Trial
Official title:
Biomarkers of Insomnia and Fatigue in HIV/AIDS
The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.
This study will characterize insomnia subtypes and identify genetic markers and metabolic
parameters associated with these subtypes. The results will be useful in later developing
interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of
HIV-infected persons.
A cross-sectional sample of 350 subjects will be recruited to describe relationships between
biomarkers and insomnia subtypes. The initial assessment will include:
- wearing a wrist actigraph for 72 hours
- providing a fasting blood sample
- measuring blood pressure, height, weight, neck, waist, hip, and thigh
- completing questionnaires
- urine screening
Depending on the results of the initial assessment, approximately 200 subjects will be
followed every month by telephone to assess symptoms and every 3 to 6 months with study
visits similar to the initial assessment. Findings from this longitudinal part of the study
will characterize the development of insomnia, fatigue, and daytime sleepiness over time in
patients living with HIV.
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Observational Model: Cohort, Time Perspective: Prospective
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