Assessment of a New AutoSet Device Designed for Female Obstructive Sleep Apnea Patients on the Quality of Life of Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
研究概览
简要总结
Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female obstructive sleep apnea manifests differently than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device has been designed specifically to treat female OSA. In this Cohort study, female patients who are newly diagnosed with OSA will be asked to complete various questionnaires relating to their quality of life. Patients will then use the AutoSet for Her for three months. At the completion of the three months the questionnaires will be repeated. Before treatment and after treatment quality of life will be compared to determine if treating female specific OSA in these patients improves quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥ 18 years
- •Diagnostic PG/ PSG showing at least moderate OSA (AHI ≥ 15)
- •Indication for PAP
- •Participants willing and able to give written informed consent
- •Ability to tolerate PAP therapy
排除标准
- •Participants currently using CPAP or who have previous experience with CPAP
- •Participants currently using supplemental oxygen
- •Participants who are pregnant or planning to become pregnant in the next 3 months
研究组 & 干预措施
AutoSet for Her PAP device
Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA
干预措施: AutoSet for Her (Device)
结局指标
主要结局
Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
时间窗: 3 months
The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome
次要结局
- Sleep Changes Assessed Through Polysomnography(3 months)