Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sleep quality score, objective measurement using the validated Likert sleep scale
研究概览
简要总结
A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.
详细描述
Objectives: Chronic pain is associated with insomnia. The objective of this clinical study is to compare the efficacy and safety of different prescribed doses of Zopiclone and Clonidine; for the management of insomnia in patients with chronic pain.
Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 was considered significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult chronic pain patients
- •good treatment compliance
- •severe chronic insomnia
- •failure of non-pharmacologic sleep therapy
- •regular zopiclone therapy for 3 months or more
- •regular sleep diary
- •regular pain diary
- •informed consent for diary review
- •consent for clinical record quality assurance review.
排除标准
- •obstructive sleep apnoea
- •body mass index (BMI) ≥40
- •organ insufficiency
- •cognitive disorder
- •inability to provide consent
- •major neuropsychiatric disorder
- •unreliable diary
- •cannabis use
- •regular alcohol intake
- •stimulant use
- •substance abuse
- •poor treatment compliance
- •high dose opioid
- •gabapentinoid use
- •sedative use
- •mild insomina
- •irregular zopiclone intake
- •regular zopiclone therapy for less than 3 months
- •previous adverse/allergic reactions to clonidine or zopiclone.
研究组 & 干预措施
Clonidine vs Zopiclone for insomnia
Consecutive adult patients who underwent pain management at a Canadian pain clinic. The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose). They were advised to take either clonidine or zopiclone on alternate nights. For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations. The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1. The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg. Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks. Therefore, each of the four medication doses was used five times by each patient.
干预措施: Clonidine 0.1mg pill (Drug)
Clonidine vs Zopiclone for insomnia
Consecutive adult patients who underwent pain management at a Canadian pain clinic. The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose). They were advised to take either clonidine or zopiclone on alternate nights. For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations. The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1. The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg. Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks. Therefore, each of the four medication doses was used five times by each patient.
干预措施: Clonidine 0.2mg pill (Drug)
Clonidine vs Zopiclone for insomnia
Consecutive adult patients who underwent pain management at a Canadian pain clinic. The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose). They were advised to take either clonidine or zopiclone on alternate nights. For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations. The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1. The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg. Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks. Therefore, each of the four medication doses was used five times by each patient.
干预措施: Zopiclone 3.75mg pill (Drug)
Clonidine vs Zopiclone for insomnia
Consecutive adult patients who underwent pain management at a Canadian pain clinic. The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose). They were advised to take either clonidine or zopiclone on alternate nights. For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations. The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1. The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg. Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks. Therefore, each of the four medication doses was used five times by each patient.
干预措施: Zopiclone 7.5mg pill (Drug)
结局指标
主要结局
Sleep quality score, objective measurement using the validated Likert sleep scale
时间窗: 3 weeks
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
次要结局
- Pain score, objective measurement using the validated Numeric Pain Rating scale(3 weeks)