Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382883
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-04-03
Brief Title:
Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment
Sponsor:
Filha ry
Organization:
Filha ry
Study Overview
Official Title:
The Impact of Individually Tailored Lifestyle and Physical Activity Intervention on Obstructive Sleep Apnea in Overweight CPAP-treated Patients in Finland A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELO
Brief Summary:
The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea OSA physical activity PA levels and sedentary behavior SB as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP Emphasis of the individually tailored SEMC-intervention protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland is on increasing the amount of total physical activity
The main questions the trial aims to answer are
Can individually tailored lifestyle intervention in combination with CPAP therapy alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA
Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life increase physical functioning change body composition and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA
Can enhanced behavioral support EBS when integrated with lifestyle intervention and CPAP therapy lead to more substantial and enduring changes in participants levels of physical activity or sedentary behavior
Participants will be randomized to either SEMC-intervention group combination of SEMC-intervention and EBS or to a control group
In this study it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms improve their quality of life body composition and physical functioning as well as increase physical activity levels and decrease their sedentary behavior compared to the control group In addition it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels and decrease their sedentary behavior to a greater extent and these changes will be more sustained compared to merely SEMC-intervention or control group
The main questions the trial aims to answer are
Can individually tailored lifestyle intervention in combination with CPAP therapy alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA
Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life increase physical functioning change body composition and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA
Can enhanced behavioral support EBS when integrated with lifestyle intervention and CPAP therapy lead to more substantial and enduring changes in participants levels of physical activity or sedentary behavior
Participants will be randomized to either SEMC-intervention group combination of SEMC-intervention and EBS or to a control group
In this study it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms improve their quality of life body composition and physical functioning as well as increase physical activity levels and decrease their sedentary behavior compared to the control group In addition it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels and decrease their sedentary behavior to a greater extent and these changes will be more sustained compared to merely SEMC-intervention or control group
Detailed Description:
Approximately 400000 adults in Finland are diagnosed with obstructive sleep apnea OSA The prevalence of OSA has dramatically increased during the past years It is estimated that substantial number of patients remain undiagnosed Untreated OSA is associated with multiple chronic diseases causing increased morbidity mortality and health care costs in the western countries Approximately 70 of patients with OSA are overweight which is the most common risk factor of OSA
While CPAP therapy often effectively alleviates symptoms of OSA it usually does not address the underlying issue as body weight often remains unchanged or even increases with CPAP therapy especially among young and women Additionally CPAP therapy has limited impact on cardiometabolic risk factors which commonly accumulate in patients with OSA Exercise even without significant weight loss has been shown to positively impact the severity of OSA and its symptoms as well as several cardiometabolic risk factors Not to mention the additional benefits of sustained weight reduction
Previous research has focused on exercise interventions that are similar for all participants There are only few studies executed in clinical real-life setting or studies with long-term follow-up periods
This clinical trial aims to investigate whether an individually tailored lifestyle intervention SEMC-protocol aimed at increasing physical activity levels will affect the severity or symptoms of OSA participants quality of life their cardiometabolic risk factors anthropometry functional capacity or induce lasting behavioral changes physical activity and sedentary behavior This trial also investigates whether enhanced behavioral support EBS will lead to more substantial and enduring changes in participants levels of physical activity and sedentary behavior
The participants n300 will be recruited at the respiratory outpatient clinic of central Hospital Nova in Jyväskylä Finland Information of the clinical trial will be provided to potential participants when starting CPAP therapy according to standard treatment The candidates will sign a written consent for a phone call from a researcher providing more information on the study After the phone call they will decide whether to sign the final informed consent to participate in the study
Participants are randomly allocated to either SEMC-intervention group combination of SEMC-intervention and EBS-intervention or to a control group Comparisons between the groups are made at 3 6 and 12months after baseline Additionally long-term assessments of the participants health status are assessed from registry data and via questionnaires at 2- 3- and five-year follow-up studies
Ethical approval for this study was obtained from the Ethics Committee of The Wellbeing Services County of Central Finland in August 2023
In the power calculations and sample size determination based on previous literature it was assumed that the change in apnea-hypopnea-index AHI for the intervention group is at least 10h 10 and for the controls it is 5 10 h Thus the sample size should be at least 126 participants 63 in the intervention group and 63 in the control group when the type I error probability is 005 and the type II error probability is 02 With this sample size the power is 08 80 Assuming a dropout rate of at least 10 for the study 100 participants will be enrolled in both the intervention and control groups
While CPAP therapy often effectively alleviates symptoms of OSA it usually does not address the underlying issue as body weight often remains unchanged or even increases with CPAP therapy especially among young and women Additionally CPAP therapy has limited impact on cardiometabolic risk factors which commonly accumulate in patients with OSA Exercise even without significant weight loss has been shown to positively impact the severity of OSA and its symptoms as well as several cardiometabolic risk factors Not to mention the additional benefits of sustained weight reduction
Previous research has focused on exercise interventions that are similar for all participants There are only few studies executed in clinical real-life setting or studies with long-term follow-up periods
This clinical trial aims to investigate whether an individually tailored lifestyle intervention SEMC-protocol aimed at increasing physical activity levels will affect the severity or symptoms of OSA participants quality of life their cardiometabolic risk factors anthropometry functional capacity or induce lasting behavioral changes physical activity and sedentary behavior This trial also investigates whether enhanced behavioral support EBS will lead to more substantial and enduring changes in participants levels of physical activity and sedentary behavior
The participants n300 will be recruited at the respiratory outpatient clinic of central Hospital Nova in Jyväskylä Finland Information of the clinical trial will be provided to potential participants when starting CPAP therapy according to standard treatment The candidates will sign a written consent for a phone call from a researcher providing more information on the study After the phone call they will decide whether to sign the final informed consent to participate in the study
Participants are randomly allocated to either SEMC-intervention group combination of SEMC-intervention and EBS-intervention or to a control group Comparisons between the groups are made at 3 6 and 12months after baseline Additionally long-term assessments of the participants health status are assessed from registry data and via questionnaires at 2- 3- and five-year follow-up studies
Ethical approval for this study was obtained from the Ethics Committee of The Wellbeing Services County of Central Finland in August 2023
In the power calculations and sample size determination based on previous literature it was assumed that the change in apnea-hypopnea-index AHI for the intervention group is at least 10h 10 and for the controls it is 5 10 h Thus the sample size should be at least 126 participants 63 in the intervention group and 63 in the control group when the type I error probability is 005 and the type II error probability is 02 With this sample size the power is 08 80 Assuming a dropout rate of at least 10 for the study 100 participants will be enrolled in both the intervention and control groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None