Evaluation of Advantages Linked to the Use of Humidification by ThermoSmart During Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Adherence
研究概览
简要总结
This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Older than 18 years of age
- •Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG).
- •Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
- •Patients receiving social security coverage (excluding MEAs)
- •Fluent spoken and written French
排除标准
- •Severe heart disease
- •Co-existing lung disease
- •Co-existing sleep disorder
- •Refused participation
研究组 & 干预措施
Thermosmart
Subjects receive heated humidification
干预措施: Heated humidification (ThermoSmart) (Device)
No humidification
Subjects use dry CPAP / APAP
干预措施: No Humidification (Device)
结局指标
主要结局
Adherence
时间窗: 8 weeks
Adherence with treatment per night averaged over total time period measured via internal software on the CPAP device and reported using InfoSmart™ software. The report will include all the supporting information recorded within the CPAP device.
次要结局
- Epworth Sleepiness Score(8 weeks)
- Subjective Dry Nose(8 weeks)
- Preference(8 weeks)
- Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)(8 weeks)
- Subjective Dry Mouth(8 weeks)
- Subjective Sinusitis(8 weeks)