RECRUITINGINTERVENTIONAL

Conventional CPAP Airsense 10 VS Portable Air-Mini CPAP For Obstructive Sleep Apnea (CASPAM)

Comparing A Conventional CPAP Airsense 10 VS Portable Air-Mini CPAP For Obstructive Sleep Apnea From Users' Perspective; A Cross - Over Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Treatments Being Tested

DEVICE

CPAP Airsense 10 vs Air-Mini

Patients' satisfaction and CPAP efficacy

Locations (1)

National University of Malaysia, Faculty of Medicine

Cheras, Kuala Lumpur, Malaysia