This study will assess the effects of the medication doxazosin on sleep in men and women with PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist actigraphy.
This pilot study will assess the effects of doxazosin on objective measures of sleep in PTSD subjects using home ambulatory polysomnography. Twenty (20) men and women with chronic PTSD will be enrolled at the San Francisco Veterans Affairs Medical Center. After initial screening, subjects will complete 1 week of baseline assessments including 2 nights of home ambulatory polysomnography. They will then participate in a 2-week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment ending with 2 nights of home polysomnography. Subjective and rater-based assessments will be conducted at baseline and at set intervals during and at the end of treatment. Wrist actigraphy measurements will also be made at baseline and at end of treatment as an economical, fairly valid and unobtrusive measure of sleep duration. We hypothesize that doxazosin will be associated with an increase in total sleep time (TST) and a decrease in wake time after sleep onset (WASO). We hypothesize that doxazosin will also be associated with clinical gains with respect to nightmares, subjective sleep quality, non-sleep PTSD symptoms, depression symptoms, and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Subjects will participate in a 2 week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy
Time frame: baseline and 8 weeks
Change in REM sleep time and REM period duration as measured by polysomnography
Time frame: baseline and 8 weeks
Change in mean scores on the CAPS, CAPS sleep and distressing dreams items, PCL, BDI, ISI, PSQI, PSQI-A and QOLI
Time frame: baseline and 8 weeks
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