The Treatment of Insomnia in Patients With HIV Disease
Status and phase
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Details and patient eligibility
About
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
Full description
Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.
Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Insomnia
- HIV Seropositive
- Stable HIV Disease
Exclusion criteria
- Other psychiatric illnesses
- Unstable HIV disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
44 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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