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A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:
A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01959022
Study type Interventional
Source San Francisco Veterans Affairs Medical Center
Contact
Status Completed
Phase Phase 4
Start date October 2013
Completion date June 2016
View Details
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