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Completed

NCT Number: NCT00503633

Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study)

The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.

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Key information

About this study

This study will characterize insomnia subtypes and identify genetic markers and metabolic parameters associated with these subtypes. The results will be useful in later developing interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of HIV-infected persons.

A cross-sectional sample of 350 subjects will be recruited to describe relationships between biomarkers and insomnia subtypes. The initial assessment will include:

  • wearing a wrist actigraph for 72 hours
  • providing a fasting blood sample
  • measuring blood pressure, height, weight, neck, waist, hip, and thigh
  • completing questionnaires
  • urine screening

Depending on the results of the initial assessment, approximately 200 subjects will be followed every month by telephone to assess symptoms and every 3 to 6 months with study visits similar to the initial assessment. Findings from this longitudinal part of the study will characterize the development of insomnia, fatigue, and daytime sleepiness over time in patients living with HIV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV infection
  • Access to a telephone
  • Able to read and write English

Exclusion criteria

  • Current use of illicit drugs
  • Currently pregnant or within the previous 3 months
  • Working nightshift
  • Diagnosis of sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movements, dementia, or psychotic illness

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Biomarkers of Insomnia and Fatigue in HIV/AIDS

Acronym: SAG

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 19, 2007
Registry last updated
Jun 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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