Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall cost of equipment
研究概览
简要总结
To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The therapy cost and the successfulness of the treatment will be measured. A humidifier is a water chamber that is currently added to CPAP only if the patients needs it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Older than 18 years of age
- •Diagnosed with OSA (obstructive sleep apnea) and eligible for CPAP treatment under local requirements (NICE guidelines: AHI (apnea hypopnea index) ≥ 15, or AHI > 5 with significant daytime sleepiness)
- •Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
- •Fluent in spoken and written English
排除标准
- •Significant uncontrolled cardiac disease, as per the principal investigator's discretion
- •Co-existing lung disease, as per the principal investigator's discretion
- •Co-existing sleep disorder, such a predominant central sleep apnoea
- •Pregnancy
- •Participants that are unable or unwilling to give informed consent.
研究组 & 干预措施
Heated humidification as first intention (HH1st)
Subjects receive heated humidification as first intention with ThermoSmart
干预措施: ThermoSmart (Device)
Non-heated humidification
Subjects will receive no humidification. However they can be switched to the humidification group if patients complains of nasal dryness, congestion, nose bleed or if they had significant leak that cannot be resolved by two changes of mask.
干预措施: Without ThermoSmart (Device)
结局指标
主要结局
Overall cost of equipment
时间窗: 6 months
(cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables
Number and type of additional interventions
时间窗: 6 months
The number and type of additional interventions (masks, nasal steroids) and the associated cost
Duration of appointments
时间窗: 6 months
Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)
Number of unplanned follow-ups
时间窗: 6 months
number of unplanned follow-ups
次要结局
- Therapy Acceptance(6 months)
- Apnea Hypopnea Index (AHI)(6 months)
- Self-reported satisfaction(6 months)
- Patient sleeping environment temperature and humidity(6 months)
- Adherence to therapy(6 months)
- Side effects and symptoms reported(6 months)
- Leak(6 months)