protocolSection identificationModule nctId: NCT06382883, orgStudyIdInfo id: FINELO2024, briefTitle: Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment, acronym: ELO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Filha ry, class: OTHER, collaborators name: University of Jyvaskyla, collaborators name: Organisation for Respiratory Health in Finland, collaborators name: Central Finland Hospital District, descriptionModule briefSummary: 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., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Individually tailored lifestyle and physical activity intervention, interventions name: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS), outcomesModule primaryOutcomes measure: Change in apnea-hypopnea-index (AHI), secondaryOutcomes measure: Change on sleep apnea symptoms, secondaryOutcomes measure: Change in the mean daily total light physical activity time, secondaryOutcomes measure: Change in the mean daily total moderate to vigorous (MVPA) physical activity time, secondaryOutcomes measure: Change in the mean daily total sedentary time, secondaryOutcomes measure: Change in 6-minute walk distance (6MWD) in meters, secondaryOutcomes measure: Change in hand grip strength in kilograms, secondaryOutcomes measure: Change in waist circumference in centimeters, secondaryOutcomes measure: Change in body weight in kilograms, secondaryOutcomes measure: Change in visceral fat area (VFA) in square centimeters, secondaryOutcomes measure: Change in muscle mass in kilograms, secondaryOutcomes measure: Change in Quality of Life RAND 36-Item Health Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Finland Hospital District, status: RECRUITING, city: Jyväskylä, zip: 40620, country: Finland, contacts name: Merja Perhonen, role: CONTACT, email: merja.perhonen@hyvaks.fi, contacts name: Antti Saarinen, role: CONTACT, email: antti.saarinen@filha.fi, geoPoint lat: 62.24147, lon: 25.72088, hasResults: False