NCT02585609已完成不适用
Sleep Quality in Patients With Advanced Cancer. A Comparison of Objective Assessments and Self-reports of Sleep Quality
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- total sleep time
研究概览
简要总结
The primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. It also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer.
The overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A verified diagnosis of a malignant disease
- •Presence of metastatic/disseminated disease
- •Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step III at the WHO pain ladder with a duration of treatment not less than 3 days
- •Able to comply with all study procedures
- •Signed informed consent according to ICH Good Clinical Practice and national/local regulations
排除标准
- •Not consenting to participation
- •Not mastering the language used at the study centre
- •Severe cognitive impairment as judged by the principal investigator
- •Any reason why, in the opinion of the investigator, the patient should not participate
- •Impaired use of the dominant arm
- •Local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour)
- •having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.
结局指标
主要结局
total sleep time
时间窗: 24 hours
1 night total sleep measured for comparison by ambulatory polysomnography (PSG), actigraphy and sleep questionnaires
次要结局
未报告次要终点
研究者
研究点 (1)
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