Comparing two types of CPAP machines for obstructive sleep apnea
Comparing A Conventional CPAP Airsense 10 VS Portable Air-Mini CPAP For Obstructive Sleep Apnea From Users' Perspective; A Cross - Over Study
This study is testing which CPAP machine, the AirSense 10 or the AirMini, works better and is more comfortable for people with moderate to severe obstructive sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT06564896 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and patient satisfaction of two CPAP machines, the AirSense 10 and the AirMini, in treating moderate to severe obstructive sleep apnea (OSA). Participants will undergo a sleep study to confirm their diagnosis and will then be randomized to use each CPAP device for a week. The study will assess overall satisfaction, apnea-hypopnea index (AHI) reduction, and other factors such as comfort and maintenance. Conducted at the National University of Malaysia, the trial will run from September 2024 to December 2026.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with moderate to severe obstructive sleep apnea.
Not a fit: Patients who are already on CPAP therapy or have certain comorbidities that worsen apnea symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and patient satisfaction for those suffering from obstructive sleep apnea.
How similar studies have performed: While there have been studies comparing CPAP devices, this specific comparison of AirSense 10 and AirMini is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Cheras, Kuala Lumpur
- National University of Malaysia, Faculty of Medicine — Cheras, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Mohamed Faisal Abdul Hamid, MBBS(IIUM) — National University of Malaysia
- Study coordinator: Mohamed Faisal Abdul Hamid, MBBS(IIUM)
- Email: faisal.hamid@ppukm.ukm.edu.my
- Phone: 0391455555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.