NCT04391699撤回不适用
Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
ResMed1 个研究点 分布在 1 个国家开始时间: 2018年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- CPAP mean usage (hours/night) at the 3 month follow up
研究概览
简要总结
To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.
详细描述
To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.
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
- None
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
- •Adult Patient
- •Newly diagnosed OSA Patients eligible to CPAP therapy
- •Signed informed consent
排除标准
- •CPAP therapy contraindications
- •Pregnancy
- •Patient unable to come to study follow up visits or unable to finish the study.
- •Informed consent not signed
- •Adults who are subject to a legal protection measure or are unable to express their consent (such as patients under guardianship and patients deprived of judicial or administrative freedom)
研究组 & 干预措施
CPAP + Heated humidification
Experimental
CPAP + Heated humidification
干预措施: heated humidification (Device)
CPAP alone
No Intervention
CPAP
结局指标
主要结局
CPAP mean usage (hours/night) at the 3 month follow up
时间窗: 3 months
therapy compliance
次要结局
- Sleep quality(3 months)
- sleepiness(3 months)
研究者
研究点 (1)
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