Description

Approximately 400,000 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 (n=300) 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 10/h ± 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 0.05 and the type II error probability is 0.2. With this sample size, the power is 0.8 (80%). Assuming a dropout rate of at least 10% for the study, 100 participants will be enrolled in both the intervention and control groups.