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Comparative Assessment of Sleep Positive Airway Pressure Modalities (CASPAM)

ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Malaysia

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • CPAP Airsense 10 vs Air-Mini

    Device

    Patients' satisfaction and CPAP efficacy

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CPAP Airsense 10Active comparator 1 intervention
Group B: CPAP AIr-MiniActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
7 days after first usage of CPAP Airsense 10
2

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

Time frame
7 days after first usage of CPAP Air-Mini

Secondary outcomes

1

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

Time frame
7 days after first usage of CPAP Airsense 10
2

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

Time frame
7 days after first usage of CPAP Air-Mini
3

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

Time frame
7 days after first usage of CPAP Airsence 10
4

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

Time frame
7 days after first usage of CPAP Air-Mini

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

National University of Malaysia, Faculty of MedicineRecruiting56000, Cheras, Kuala LumpurMalaysiaMalaysia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Malaysia

Lead sponsor

Source ClinicalTrials.gov
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