Obstructive Sleep ApneaCASPAMNCT06564896
Comparative Assessment of Sleep Positive Airway Pressure Modalities (CASPAM)
A study testing CPAP Airsense 10 vs Air-Mini in people with Obstructive Sleep Apnea, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP Airsense 10 vs Air-Mini
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
National University of Malaysia, Faculty of Medicine
Cheras, Kuala Lumpur, 56000
Mohamed Faisal Abdul Hamid, 0391455555, faisal.hamid@ppukm.ukm.edu.my
About this study
Official title: 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
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.
Read the detailed description
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.
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP Airsense 10 vs Air-Mini
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP Airsense 10 vs Air-MiniDevice
Patients' satisfaction and CPAP efficacy
| Study group | Role | What they receive |
|---|---|---|
| CPAP Airsense 10 | Active comparator | Participants in CPAP Airsense 10 Receives: Device: CPAP Airsense 10 vs Air-Mini |
| CPAP AIr-Mini | Active comparator | Participants in CPAP AIr-Mini Receives: Device: CPAP Airsense 10 vs Air-Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 days after first usage of CPAP Air-Mini
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days after first usage of CPAP Air-Mini
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Faisal Abdul Hamid, MBBS(IIUM), Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564896
- Sponsor's protocol ID
- FF-2024-303
- Acronym
- CASPAM
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 34381578Ryan 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.
PubMed 19561283Rotenberg 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.
PubMed 27048606
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06564896
- Acronym / sponsor ID
- CASPAM / FF-2024-303
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Airsense 10 | Active comparator | Device: CPAP Airsense 10 vs Air-MiniParticipants in CPAP Airsense 10 |
| CPAP AIr-Mini | Active comparator | Device: CPAP Airsense 10 vs Air-MiniParticipants in CPAP AIr-Mini |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP Airsense 10 vs Air-MiniPatients' satisfaction and CPAP efficacy | Device | CPAP AIr-Mini, CPAP Airsense 10 |
Primary outcome
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)
Time frame: 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)
Time frame: 7 days after first usage of CPAP Air-Mini
Participants with moderate to severe OSA who underwent CPAP trial using CPAP Air Mini
12 secondary outcomes
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)
Time frame: 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)
Time frame: 7 days after first usage of CPAP Air-Mini
To determine the average 95th centile pressure required using conventional CPAP Airsense 10
Time frame: 7 days after first usage of CPAP Airsence 10
To determine the average 95th centile pressure required using CPAP Air-Mini
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 days after first usage of CPAP Air-Mini
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 34381578Abbasi 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.
- Results publication: PubMed 19561283Ryan 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.
- Results publication: PubMed 27048606Rotenberg 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.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Faisal Abdul Hamid, MBBS(IIUM) principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP Airsense 10 vs Air-Mini in people with Obstructive Sleep Apnea, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Faisal Abdul Hamid, MBBS(IIUM) (0391455555, faisal.hamid@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 7 days after first usage of CPAP Airsense 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564896, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.