Comparative Assessment of Sleep Positive Airway Pressure Modalities (CASPAM) Trial: Conventional CPAP (AirSense 10) Versus Portable CPAP (AirMini) in Patients With Obstructive Sleep Apnea-A Randomized Crossover Study of User Preference
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To compare the overall satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving conventional CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied)
研究概览
简要总结
Obstructive sleep apnea (OSA) has been one of the topmost global health problems. It is an underdiagnosed disease which have a huge burden on healthcare if left untreated. Almost 80-90% of adults are underdiagnosed of OSA Obesity primarily is one of the supreme risk factors for developing OSA. Globally, obesity cases have risen affecting almost two billion people. According to National Health and Morbidity Survey (NHMS) 2019, 1 in 2 adults in Malaysia were overweight or obese. Report from World Obesity Atlas 2023 predicts that adult obesity will rise 4.7% annually from 2020 - 2035, while child obesity will increase by 5.3% per year over similar timeline. Overweight individuals will have a significant economic impact on Malaysia's Gross Domestic Product (GDP) by 2035 by 2.8% which is estimated to be about RM 3.2 trillion.
Sequalae of OSA is divided into two (cardiovascular-metabolic effect and neurocognitive effect). This group of patients are at high risk of developing hypertension, insulin resistance, dyslipidemia which then leads to pulmonary hypertension and heart failure. More importantly, from the neurocognitive point of view, persistent sleep deprivation will lead to poor concentration, impaired memory, personality changes affecting overall self-performance which can lead to depression and compromising safety as they have higher risk of work-related accidents.
详细描述
Hypothesis
- Participants' overall satisfaction is better using Air-Mini CPAP compared to Airsense CPAP machine.
- There is no difference in terms of AHI reduction and average 95th centile pressure required between AirMini CPAP compared to Airsense CPAP machine.
- There will be positive correlation between overall satisfaction and AHI reduction for Air-Mini CPAP compared to Airsense CPAP machine.
- There is improvement in air leak, comfort, compactness and maintenance in AirMini CPAP machine compared to AirSense CPAP.
This is a prospective cross over trial study of group of patients with moderate to severe OSA based on the severity of the AHI.
This study will be conducted for all moderate to severe OSA participants in Hospital Canselor Tuanku Muhriz (medical and non-medical department) between September 2024 to December 2026.
This is a cross over trial that includes patients with medium to high risk of OSA according to STOPBANG score. Once these group of participants are selected, consent will be taken from them to go through a scheduled sleep study. Diagnosis is established after AHI score is concluded from the polysomnographic study. Those who are diagnosed with moderate to high AHI score will be recruited in this study. All subjects will be given a CPAP trial using both AirSense and AirMini model for 7 days each device. Upon recruitment, the subject will be randomised using 1:1 block randomisation either to receive AIrsense 10 CPAP machine or Air-mini CPAP machine.
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
- 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
- •Aged ≥ 18 years.
- •Patients diagnosed with moderate to severe OSA (based on AHI classification from sleep study performed).
- •Patients who are able to understand and answer the questionnaire given.
排除标准
- •Patients who are unable to give consent to the study.
- •Patients who have been diagnosed with OSA and already on CPAP machine.
- •Patients who had underlying Obesity Hypoventilation Syndrome (OHS).
- •Patients who had underlying co-morbidities that worsen apnea symptoms, such as congestive cardiac failure, active malignancy, narcolepsy, active alcohol or drug abuse, treatment-refractory dementia, psychotic illness and active use of drugs that disturb the sleep architecture (i.e hypnotics or stimulants of central nervous system).
研究组 & 干预措施
CPAP AIr-Mini
Participants in CPAP AIr-Mini
干预措施: CPAP Airsense 10 vs Air-Mini (Device)
CPAP Airsense 10
Participants in CPAP Airsense 10
干预措施: CPAP Airsense 10 vs Air-Mini (Device)
结局指标
主要结局
To compare the overall satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving conventional CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied)
时间窗: 7 days after first usage of CPAP Airsense 10
Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 10
To compare the overall satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Air-Mini. (0 mm - Not Satisfied at all, 100mm - Very Satisfied)
时间窗: 7 days after first usage of CPAP Air-Mini
Participants with moderate to severe OSA who underwent CPAP trial using CPAP Air Mini
次要结局
- To determine the average 95th centile pressure required using CPAP Air-Mini(7 days after first usage of CPAP Air-Mini)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Air-Mini (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of comfort(7 days after first usage of CPAP Air-Mini)
- To evaluate the efficacy of CPAP machine Air-Mini 10 in terms of percentage AHI reduction (Optimal titration=AHI <5, Good titration=AHI ≤10 or by 50%, Adequate titration= AHI reduction by 75% from baseline)(7 days after first usage of CPAP Air-Mini)
- To determine the average 95th centile pressure required using conventional CPAP Airsense 10(7 days after first usage of CPAP Airsence 10)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Air Mini (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of air leak(7 days after first usage of CPAP Air-Mini)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Air-Mini (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of compactness & portability(7 days after first usage of CPAP Air-Mini)
- To evaluate the efficacy of CPAP machine Airsense 10 in terms of percentage AHI reduction (Optimal titration=AHI <5, Good titration=AHI ≤10 or by 50%, Adequate titration= AHI reduction by 75% from baseline)(7 days after first usage of CPAP Airsense 10)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving conventional CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of air leak(7 days after first usage of CPAP Airsence 10)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of comfort(7 days after first usage of CPAP Airsence 10)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of compactness & portability(7 days after first usage of CPAP Airsence 10)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of maintenance & configuration(7 days after first usage of CPAP Airsence 10)
- To compare the satisfaction using Visual Analogue Score 100mm among moderate to severe OSA participants receiving CPAP Air-Mini (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of maintenance & configuration(7 days after first usage of CPAP Air-Mini)