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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00503633
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-19
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States