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

NCT06564896 | Recruiting FDA Device

• 1 other identifier: FF-2024-303
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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 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)

  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)

  7 days after first usage of CPAP Air-Mini

• To determine the average 95th centile pressure required using conventional CPAP Airsense 10

  7 days after first usage of CPAP Airsence 10

• To determine the average 95th centile pressure required 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

  7 days after first usage of CPAP Airsence 10

Study Arms (2)

CPAP Airsense 10

ACTIVE COMPARATOR

Participants in CPAP Airsense 10

Device: CPAP Airsense 10 vs Air-Mini

CPAP AIr-Mini

ACTIVE COMPARATOR

Participants in CPAP AIr-Mini

Device: CPAP Airsense 10 vs Air-Mini

Interventions

CPAP Airsense 10 vs Air-Mini DEVICE

Patients' satisfaction and CPAP efficacy

CPAP AIr-Mini; CPAP Airsense 10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University of Malaysia, Faculty of Medicine

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (3)

• 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.

  PMID: 34381578 RESULT

• 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.

  PMID: 19561283 RESULT

• 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.

  PMID: 27048606 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mohamed Faisal Abdul Hamid, MBBS(IIUM)

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Faisal Abdul Hamid, MBBS(IIUM)

CONTACT

0391455555; faisal.hamid@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)