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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: CPAP Airsense 10 vs Air-Mini

Detailed Description

Hypothesis

1. Participants' overall satisfaction is better using Air-Mini CPAP compared to Airsense CPAP machine.
2. There is no difference in terms of AHI reduction and average 95th centile pressure required between AirMini CPAP compared to Airsense CPAP machine.
3. There will be positive correlation between overall satisfaction and AHI reduction for Air-Mini CPAP compared to Airsense CPAP machine.
4. 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.

Those participants that use AirSense CPAP machine first for 7 days will be given a set of Questionnaire at the end of 7th day of the trial. Subsequently, they will be switch to use Air-Mini CPAP machine for another 7 days and the same set Questionnaire will be given on the 7th day of the trial. The type of the interface used will be based on subject's preferences, i.e., full face mask / nasal masak / nasal pillow, during the initial 1 - 2 days of CPAP trial. The same interface as per subject's preferences will be used throughout the CPAP trials for both AirSense as well as Airmini CPAP machine.

The Questionnaire given comprises of a 100mm Visual Analogue Score (VAS) for: 1) Overall satisfaction, 2) Air Leak, 3) Comfort, 4) Compactness & Portability, 5) Maintenance & Configuration.

The data collected will be analyzed using SPSS Version 27.

This is a cross-sectional prospective study; hence the sample size calculation will be based on Machin et al. (2018) The sample size decided for this study was 40 subjects. Considering and taking into account of about 10% dropout / missing data, hence the total sample size that will be recruited for this study are 50 subjects.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Faisal Abdul Hamid, MBBS(IIUM); Phone Number: 0391455555; Email: faisal.hamid@ppukm.ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Recruiting
      • National University of Malaysia, Faculty of Medicine
      • Contact: Mohamed Faisal Abdul Hamid; Phone Number: 0391455555; Email: faisal.hamid@ppukm.ukm.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP Airsense 10; Participants in CPAP Airsense 10	Device: CPAP Airsense 10 vs Air-Mini; Patients' satisfaction and CPAP efficacy
Active Comparator: CPAP AIr-Mini; Participants in CPAP AIr-Mini	Device: CPAP Airsense 10 vs Air-Mini; Patients' satisfaction and CPAP efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Mohamed Faisal Abdul Hamid, MBBS(IIUM), National University of Malaysia

Publications and helpful links

General Publications

• Abbasi A, Gupta SS, Sabharwal N, Meghrajani V, Sharma S, Kamholz S, Kupfer Y. A comprehensive review of obstructive sleep apnea. Sleep Sci. 2021 Apr-Jun;14(2):142-154. doi: 10.5935/1984-0063.20200056.
• Ryan S, Taylor CT, McNicholas WT. Systemic inflammation: a key factor in the pathogenesis of cardiovascular complications in obstructive sleep apnoea syndrome? Thorax. 2009 Jul;64(7):631-6. doi: 10.1136/thx.2008.105577.
• Rotenberg BW, Vicini C, Pang EB, Pang KP. Reconsidering first-line treatment for obstructive sleep apnea: a systematic review of the literature. J Otolaryngol Head Neck Surg. 2016 Apr 6;45:23. doi: 10.1186/s40463-016-0136-4.

Helpful Links

• Shah NA, Yaggi HK, Concato J, et. al . Obstructive sleep apnea as a risk factor for coronary events or cardiovascular death. Sleep and Breathing. 2010 Jun;14:131-6.
• Meslier N, Lebrun T, Grillier-Lanoir V, et.al . A French survey of 3,225 patients treated with CPAP for obstructive sleep apnoea: benefits, tolerance, compliance and quality of life. European Respiratory Journal. 19

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 5, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: FF-2024-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes