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

Biomarkers of Insomnia and Fatigue in HIV/AIDS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00503633
Acronym
SAG
Enrollment
350
Registered
2007-07-19
Start date
2005-03-31
Completion date
2009-05-31
Last updated
2010-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

sleep disorders, genetics

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026