Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment - Trial NCT06382883
Access comprehensive clinical trial information for NCT06382883 through Pure Global AI's free database. This phase not specified trial is sponsored by Filha ry and is currently Recruiting. The study focuses on Obstructive Sleep Apnea. Target enrollment is 300 participants.
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Study Focus
Individually tailored lifestyle and physical activity intervention
Interventional
behavioral
Sponsor & Location
Filha ry
Timeline & Enrollment
N/A
Apr 22, 2024
Jul 31, 2026
Primary Outcome
Change in apnea-hypopnea-index (AHI)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06382883
Non-Device Trial