NCT03281525已完成不适用
Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study
University of Padova1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2017年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Sleep Quality Index
研究概览
简要总结
The SQ_Heart has been designed as an observational study that evaluates the difference in sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98 Cardiotransplant patients.
详细描述
The Primary objective of the SQ_Heart study is to evaluate the significant difference in sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of > 5 for poor sleepers.
Patients, to be enrolled, must provide:
- Age ≥ 18 and < 90;
- Cardiotransplant patients, with VAD or non;
- patients with VAD.
- subjects able to sign informed consent.
All the patients will have to complete some questionnaires:
- questionnaire about the diagnosis of pathology and lifestyle;
- questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep Quality (PSQI);
- questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and < 90;
- •Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;
- •patients with VAD ;
- •subjects able to sign informed consent.
排除标准
- •Age < 18;
- •subjects don't sign informed consent;
- •hospitalization for more than 30 days before compilation in intensive care unit.
结局指标
主要结局
Sleep Quality Index
时间窗: up 30 days
sleep quality
次要结局
未报告次要终点
研究者
研究点 (1)
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