SleepNCT00253695
Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents
An observational study of Sleep and HIV Infections, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, HIV Infections
- What is being tested?
- Wrist Actigraphy
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: HIV-infected children with and without asthma.
Who may be able to join
- HIV Group
- HIV-1 infection
- Control Group
- Family members and friends of HIV-1 infected children
Who cannot join
- HIV Group
- Pregnancy
- Control Group
- Pregnancy
- Asthma
- Sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Sleep, HIV Infections
- Being tested
- Wrist Actigraphy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist ActigraphyDevice
Wrist actigraph will record participants' sleeping patterns.
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV.
Observational study only
Measured: 11/2005 - 02/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJul 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, William Shearer, Baylor College of Medicine
- Investigators
- William Shearer, MD, PhD, Principal investigator, Texas Children's Hospital/Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253695
- Sponsor's protocol ID
- 1317
- Other IDs
- R01HL079533
- Status last verified
- Mar 2013
- First submitted
- 10 Nov 2005
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Foster SB, Paul ME, Kozinetz CA, Macias CG, Shearer WT. Prevalence of asthma in children and young adults with HIV infection. J Allergy Clin Immunol. 2007 Mar;119(3):750-2. doi: 10.1016/j.jaci.2007.01.002. No abstract available.
PubMed 17336620Foster SB, Paul ME, Glaze DG, Reuben JM, Harris LL, Cohen EN, Lee B-N, Kozinetz CA, Schwarzwald HL, Kline MW, Jackson CD, Loeb AJ, Frerking PR, Brouwers PY, Shearer WT. Viremia is associated with sleep disturbances, neurocognitive disorders and cytokine dysregulation in pediatric HIV infection. J Allergy Clin Immunol 2007;119;S232.
Alvarez JA, Scully RE, Miller TL, Armstrong FD, Constine LS, Friedman DL, Lipshultz SE. Long-term effects of treatments for childhood cancers. Curr Opin Pediatr. 2007 Feb;19(1):23-31. doi: 10.1097/MOP.0b013e328013c89e.
PubMed 17224658Armstrong FD. Neurodevelopment and chronic illness: Mechanisms of disease and treatment. Ment Retard Dev Disabil Res Rev. 2006;12(3):168-73. doi: 10.1002/mrdd.20114.
PubMed 17061286Fisher SD, Miller TL, Lipshultz SE. Impact of HIV and highly active antiretroviral therapy on leukocyte adhesion molecules, arterial inflammation, dyslipidemia, and atherosclerosis. Atherosclerosis. 2006 Mar;185(1):1-11. doi: 10.1016/j.atherosclerosis.2005.09.025. Epub 2005 Nov 16.
PubMed 16297390Kozinetz CA, Matusa R, Hacker CS. Biologic and social determinants of sequelae and long-term survival of pediatric HIV in Romania. Ann Epidemiol. 2006 Aug;16(8):593-9. doi: 10.1016/j.annepidem.2005.11.012. Epub 2006 Jan 23.
PubMed 16431133Lewis DE, Gross KL, Diez MM, Martinez ML, Lukefahr HN, Kozinetz CA, Arduino RC. CD8 apoptosis may be a predictor of T cell number normalization after immune reconstitution in HIV. J Transl Med. 2007 Jan 30;5:9. doi: 10.1186/1479-5876-5-9.
PubMed 17263884Lipshultz SE, Fisher SD, Sharma T, Milton A, Miller TL. HIV-associated cardiovascular disease. Dialogues in Cardiology 2007, in press.
Macias CG, Caviness AC, Sockrider M, Brooks E, Kronfol R, Bartholomew LK, Abramson S, Shearer W. The effect of acute and chronic asthma severity on pediatric emergency department utilization. Pediatrics. 2006 Apr;117(4 Pt 2):S86-95. doi: 10.1542/peds.2005-2000F.
PubMed 16777836Mitchell CD, Armstrong FD, Goodman KW, Cava A. Disclosure of HIV status to an infected child: medical, psychological, ethical, and legal perspectives in an era of "super-vertical" transmission. J Clin Ethics. 2008 Spring;19(1):43-52. No abstract available.
PubMed 18552052Nathan PC, Patel SK, Dilley K, Goldsby R, Harvey J, Jacobsen C, Kadan-Lottick N, McKinley K, Millham AK, Moore I, Okcu MF, Woodman CL, Brouwers P, Armstrong FD; Children's Oncology Group Long-term Follow-up Guidelines Task Force on Neurocognitive/Behavioral Complications After Childhood Cancer. Guidelines for identification of, advocacy for, and intervention in neurocognitive problems in survivors of childhood cancer: a report from the Children's Oncology Group. Arch Pediatr Adolesc Med. 2007 Aug;161(8):798-806. doi: 10.1001/archpedi.161.8.798.
PubMed 17679663Shearer WT, DeVille JG, Samson PM, Moye JH Jr, Fletcher CV, Church JA, Spiegel HM, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JM, Olson WC. Susceptibility of pediatric HIV-1 isolates to recombinant CD4-IgG2 (PRO 542) and humanized mAb to the chemokine receptor CCR5 (PRO 140). J Allergy Clin Immunol. 2006 Aug;118(2):518-21. doi: 10.1016/j.jaci.2006.03.028. Epub 2006 May 19. No abstract available.
PubMed 16890780Pacheco SE, McIntosh K, Lu M, Mofenson LM, Diaz C, Foca M, Frederick M, Handelsman E, Hayani K, Shearer WT; Women and Infants Transmission Study. Effect of perinatal antiretroviral drug exposure on hematologic values in HIV-uninfected children: An analysis of the women and infants transmission study. J Infect Dis. 2006 Oct 15;194(8):1089-97. doi: 10.1086/507645. Epub 2006 Sep 11.
PubMed 16991083Williamson MP, McCormick TG, Nance CL, Shearer WT. Epigallocatechin gallate, the main polyphenol in green tea, binds to the T-cell receptor, CD4: Potential for HIV-1 therapy. J Allergy Clin Immunol. 2006 Dec;118(6):1369-74. doi: 10.1016/j.jaci.2006.08.016. Epub 2006 Oct 13.
PubMed 17157668HIV Paediatric Prognostic Markers Collaborative Study. Predictive value of absolute CD4 cell count for disease progression in untreated HIV-1-infected children. AIDS. 2006 Jun 12;20(9):1289-94. doi: 10.1097/01.aids.0000232237.20792.68.
PubMed 16816558
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Studies in HIV+ Older Children/Adolescents
- ClinicalTrials.gov ID
- NCT00253695
- Acronym / sponsor ID
- 1317
- Conditions
- Sleep, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- HIV-infected children with and without asthma.
Key inclusion criteria (4 listed)
- HIV Group
- HIV-1 infection
- Control Group
- Family members and friends of HIV-1 infected children
Key exclusion criteria (6 listed)
- HIV Group
- Pregnancy
- Control Group
- Pregnancy
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist ActigraphyWrist actigraph will record participants' sleeping patterns. | Device | – |
Primary outcome
Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV.
Time frame: 11/2005 - 02/2009
Observational study only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
- Background: PubMed 17336620Foster SB, Paul ME, Kozinetz CA, Macias CG, Shearer WT. Prevalence of asthma in children and young adults with HIV infection. J Allergy Clin Immunol. 2007 Mar;119(3):750-2. doi: 10.1016/j.jaci.2007.01.002. No abstract available.
- BackgroundFoster SB, Paul ME, Glaze DG, Reuben JM, Harris LL, Cohen EN, Lee B-N, Kozinetz CA, Schwarzwald HL, Kline MW, Jackson CD, Loeb AJ, Frerking PR, Brouwers PY, Shearer WT. Viremia is associated with sleep disturbances, neurocognitive disorders and cytokine dysregulation in pediatric HIV infection. J Allergy Clin Immunol 2007;119;S232.
- Background: PubMed 17224658Alvarez JA, Scully RE, Miller TL, Armstrong FD, Constine LS, Friedman DL, Lipshultz SE. Long-term effects of treatments for childhood cancers. Curr Opin Pediatr. 2007 Feb;19(1):23-31. doi: 10.1097/MOP.0b013e328013c89e.
- Background: PubMed 17061286Armstrong FD. Neurodevelopment and chronic illness: Mechanisms of disease and treatment. Ment Retard Dev Disabil Res Rev. 2006;12(3):168-73. doi: 10.1002/mrdd.20114.
- Background: PubMed 16297390Fisher SD, Miller TL, Lipshultz SE. Impact of HIV and highly active antiretroviral therapy on leukocyte adhesion molecules, arterial inflammation, dyslipidemia, and atherosclerosis. Atherosclerosis. 2006 Mar;185(1):1-11. doi: 10.1016/j.atherosclerosis.2005.09.025. Epub 2005 Nov 16.
- Background: PubMed 16431133Kozinetz CA, Matusa R, Hacker CS. Biologic and social determinants of sequelae and long-term survival of pediatric HIV in Romania. Ann Epidemiol. 2006 Aug;16(8):593-9. doi: 10.1016/j.annepidem.2005.11.012. Epub 2006 Jan 23.
- Background: PubMed 17263884Lewis DE, Gross KL, Diez MM, Martinez ML, Lukefahr HN, Kozinetz CA, Arduino RC. CD8 apoptosis may be a predictor of T cell number normalization after immune reconstitution in HIV. J Transl Med. 2007 Jan 30;5:9. doi: 10.1186/1479-5876-5-9.
- BackgroundLipshultz SE, Fisher SD, Sharma T, Milton A, Miller TL. HIV-associated cardiovascular disease. Dialogues in Cardiology 2007, in press.
- Background: PubMed 16777836Macias CG, Caviness AC, Sockrider M, Brooks E, Kronfol R, Bartholomew LK, Abramson S, Shearer W. The effect of acute and chronic asthma severity on pediatric emergency department utilization. Pediatrics. 2006 Apr;117(4 Pt 2):S86-95. doi: 10.1542/peds.2005-2000F.
- Background: PubMed 18552052Mitchell CD, Armstrong FD, Goodman KW, Cava A. Disclosure of HIV status to an infected child: medical, psychological, ethical, and legal perspectives in an era of "super-vertical" transmission. J Clin Ethics. 2008 Spring;19(1):43-52. No abstract available.
- Background: PubMed 17679663Nathan PC, Patel SK, Dilley K, Goldsby R, Harvey J, Jacobsen C, Kadan-Lottick N, McKinley K, Millham AK, Moore I, Okcu MF, Woodman CL, Brouwers P, Armstrong FD; Children's Oncology Group Long-term Follow-up Guidelines Task Force on Neurocognitive/Behavioral Complications After Childhood Cancer. Guidelines for identification of, advocacy for, and intervention in neurocognitive problems in survivors of childhood cancer: a report from the Children's Oncology Group. Arch Pediatr Adolesc Med. 2007 Aug;161(8):798-806. doi: 10.1001/archpedi.161.8.798.
- Background: PubMed 16890780Shearer WT, DeVille JG, Samson PM, Moye JH Jr, Fletcher CV, Church JA, Spiegel HM, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JM, Olson WC. Susceptibility of pediatric HIV-1 isolates to recombinant CD4-IgG2 (PRO 542) and humanized mAb to the chemokine receptor CCR5 (PRO 140). J Allergy Clin Immunol. 2006 Aug;118(2):518-21. doi: 10.1016/j.jaci.2006.03.028. Epub 2006 May 19. No abstract available.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Shearer, MD, PhD principal investigator
Texas Children's Hospital/Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and HIV Infections, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV. (time frame: 11/2005 - 02/2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253695, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.