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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• A physician-diagnosed, moderate to severe obstructive sleep apnea

• BMI \> 25

• Age 18- to 70-years

• No previous CPAP-treatment

Locations
Other Locations
Finland
Central Finland Hospital District
RECRUITING
Jyväskylä
Contact Information
Primary
Hanna Renkola
hanna.renkola@filha.fi
+358504009490
Backup
Antti Saarinen
antti.saarinen@filha.fi
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 300
Treatments
Experimental: SEMC-protocol
Assigned participants will receive CPAP-therapy and one year individually tailored lifestyle intervention at the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland (SEMC).
Experimental: SEMC-protocol + EBS intervention
Assigned participants will receive CPAP-therapy, SEMC-protocol as described above and enhanced behavioral support -intervention (EBS). The EBS-intervention will apply a patient-centered self-regulatory approach to support (motivation for) changes in behavior (CPAP-use, physical activity (PA), and sedentary behavior (SB)).
No_intervention: Control group
Assigned participants will receive CPAP-therapy, receive written information on healthy lifestyle but will not receive any extra support.
Related Therapeutic Areas
Sponsors
Collaborators: University of Jyvaskyla, Central Finland Hospital District, Organisation for Respiratory Health in Finland
Leads: Filha ry

This content was sourced from clinicaltrials.gov