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临床试验/NCT00465972
NCT00465972已完成4 期

A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.

Duke University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Response: Change in Insomnia Severity Rating Scale at 3 Months.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV Seropositive
  • Stable HIV Disease

排除标准

  • Other psychiatric illnesses
  • Unstable HIV disease

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

2

Active Comparator

Doxepin

干预措施: Doxepin (Drug)

3

Active Comparator

Temazepam

干预措施: Temazepam (Drug)

结局指标

主要结局

Response: Change in Insomnia Severity Rating Scale at 3 Months.

时间窗: Baseline and 3 months

Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.

次要结局

  • Change in Piper Fatigue Scale at 3 Months(Baseline and 3 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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