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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Shearer, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00253695
First received: November 10, 2005
Last updated: March 26, 2013
Last verified: March 2013

November 10, 2005
March 26, 2013
July 2004
September 2009   (final data collection date for primary outcome measure)
Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV. [ Time Frame: 11/2005 - 02/2009 ] [ Designated as safety issue: No ]
Observational study only
Not Provided
Complete list of historical versions of study NCT00253695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents
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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood

Probability Sample

HIV-infected children with and without asthma.

  • Sleep
  • HIV Infections
Device: Wrist Actigraphy
Wrist actigraph will record participants' sleeping patterns.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
8 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00253695
1317, R01HL079533
No
William Shearer, Baylor College of Medicine
Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: William Shearer, MD, PhD Texas Children's Hospital/Baylor College of Medicine
Baylor College of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP