Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study) (SAG)
The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Biomarkers of Insomnia and Fatigue in HIV/AIDS|
|Study Start Date:||March 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503633
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Kathryn A Lee, PhD||University of California, San Francisco|