Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564896
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Conventional CPAP Airsense 10 VS Portable Air-Mini CPAP For Obstructive Sleep Apnea CASPAM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing A Conventional CPAP Airsense 10 VS Portable Air-Mini CPAP For Obstructive Sleep Apnea From Users Perspective A Cross - Over Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASPAM
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 47 annually from 2020 - 2035 while child obesity will increase by 53 per year over similar timeline Overweight individuals will have a significant economic impact on Malaysias Gross Domestic Product GDP by 2035 by 28 which is estimated to be about RM 32 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
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
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 11 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 subjects preferences ie full face mask nasal masak nasal pillow during the initial 1 - 2 days of CPAP trial The same interface as per subjects 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
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 11 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 subjects preferences ie full face mask nasal masak nasal pillow during the initial 1 - 2 days of CPAP trial The same interface as per subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None