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Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents

Sleep Studies in HIV+ Older Children/Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00253695
Enrollment
90
Registered
2005-11-15
Start date
2004-07-31
Completion date
2009-09-30
Last updated
2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sleep

Brief summary

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.

Detailed description

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.

Interventions

DEVICEWrist Actigraphy

Wrist actigraph will record participants' sleeping patterns.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

HIV Group * HIV-1 infection Control Group * Family members and friends of HIV-1 infected children

Exclusion criteria

HIV Group * Pregnancy Control Group * Pregnancy * Asthma * Sleep apnea

Design outcomes

Primary

MeasureTime frameDescription
Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV.11/2005 - 02/2009Observational study only

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026