Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT00253695|
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : March 28, 2013
|Condition or disease||Intervention/treatment|
|Sleep HIV Infections||Device: Wrist Actigraphy|
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.
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Observational Model:||Case Control|
|Official Title:||Sleep Studies in HIV+ Older Children/Adolescents|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
- Device: Wrist Actigraphy
Wrist actigraph will record participants' sleeping patterns.
- Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV. [ Time Frame: 11/2005 - 02/2009 ]Observational study only
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253695
|United States, Texas|
|Texas Children's Hospital/Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William Shearer, MD, PhD||Texas Children's Hospital/Baylor College of Medicine|