HIV Infections Clinical Trial
Official title:
Sleep Studies in HIV+ Older Children/Adolescents
This study is a first step in approaching the gap existing between understanding sleep abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating cytokines, and abnormal higher cortical function.
BACKGROUND:
In the growing number of HIV infected youth and young adults, it is important to study the
effects of HAART treatment on sleep patterns and related neurocognitive and psychosocial
function.
DESIGN NARRATIVE (including primary and secondary outcomes):
Using validated sleep questionnaires and actigraphy measurements, overnight polysomnography
(PSG, sleep study) will assess the degree of abnormal sleeping patterns and daytime
sleepiness in HIV infected children and HIV uninfected children (control group).
The following peripheral blood levels will be measured over a 24-hour period, at multiple
time points, in all participants: TNF-alphaRI and IL-6 (sleep-regulating cytokines);
IFN-gamma and IL-12 (cytotoxic or TH1 cytokines); and IL-10 and IL-1RA (inflammatory or TH2
cytokines). This will help to determine the association between alterations in
sleep-regulating cytokines and HIV disease progression (CD4+ T-cell count, HIV-1 RNA level).
Neurocognitive and neuropsychological tests will be performed on all participants to
determine if there is an association between lack of normal sleeping habits, alterations in
sleep-regulating cytokines and HIV-1 disease progression cytokines, and
neurocognitive/neuropsychological performance.
Computer analysis of electroencephalography (EEG) will be performed during wakefulness and
all stages of sleep to determine if greater disease severity, sleepiness, sleep disruption,
and neurocognitive impairment is associated with increased amounts of slow activity.
Improvement in these related factors will be associated with normalizations of these
parameters. For some of these quantitative measures, the findings may be more significant
for particular brain regions; for example, frontal regions in the case of attention
problems.
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Observational Model: Case Control, Time Perspective: Prospective
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