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

Completed

• Conditions: Sleep; HIV Infections

• Registration Number: NCT00253695
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Texas Children's Hospital/Baylor College of Medicine; 🇺🇸 Houston, Texas, United States