Conventional CPAP Airsense 10 VS Portable Air-Mini CPAP For Obstructive Sleep Apnea (CASPAM)
NCT Number: NCT06564896
Acronym: CASPAM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: DEVICE: CPAP Airsense 10 vs Air-Mini
Sponsor: National University of Malaysia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-01-01
Locations: National University of Malaysia, Faculty of Medicine, Cheras, Kuala Lumpur, 56000, Malaysia

Summary:
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.

Primary Outcome Measures: 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), Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 10, 7 days after first usage of CPAP Airsense 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), Participants with moderate to severe OSA who underwent CPAP trial using CPAP Air Mini, 7 days after first usage of CPAP Air-Mini
Secondary Outcome Measures: 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), Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsense 10, 7 days after first usage of CPAP Airsense 10|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), Participants with moderate to severe OSA who underwent CPAP trial using CPAP Air-Mini, 7 days after first usage of CPAP Air-Mini|To determine the average 95th centile pressure required using conventional CPAP Airsense 10, Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 10, 7 days after first usage of CPAP Airsence 10|To determine the average 95th centile pressure required using CPAP Air-Mini, Participants with moderate to severe OSA who underwent CPAP trial 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 conventional CPAP Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of air leak, Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 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, Participants with moderate to severe OSA who underwent CPAP trial using 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 Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of comfort, Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 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 comfort, Participants with moderate to severe OSA who underwent CPAP trial 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 Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of compactness & portability, Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 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 compactness & portability, Participants with moderate to severe OSA who underwent CPAP trial 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 Airsense 10 (0 mm - Not Satisfied at all, 100mm - Very Satisfied), in terms of maintenance & configuration, Participants with moderate to severe OSA who underwent CPAP trial using CPAP Airsence 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 maintenance & configuration, Participants with moderate to severe OSA who underwent CPAP trial using CPAP Air-Mini, 7 days after first usage of CPAP Air-Mini