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Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment

Key facts

Who runs it
Filha ry
Where
Finland1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
300 people, planned
Started
18 Apr 2024
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Individually tailored lifestyle and physical activity intervention
  • Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)
Record updated
12 August 2025

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • A physician-diagnosed, moderate to severe obstructive sleep apnea
  • BMI > 25
  • Age 18- to 70-years
  • No previous CPAP-treatment

Who cannot take part

  • Weight-loss medication initiated less than 3 months before recruiting
  • Chronic Obstructive Pulmonary Disease (COPD) or other severe conditions affecting nighttime oxygenation (mild asthma is acceptable), Obesity Hypoventilation Syndrome without sleep apnea
  • Aggressive cancer or any other condition requiring intense treatments
  • Conditions severely impairing daily functioning (e.g., serious mental health issues, narcolepsy, severe comorbidities, profound fibromyalgia, musculoskeletal problems significantly limiting mobility and accordingly, participation in the intervention)
  • Conditions and diseases influencing the participant's ability to make independent decisions
  • Participants under 18 years of age
  • Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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 3 groups in the trial

  • SEMC-protocolTreatment being tested

    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).

    Treatment: Individually tailored lifestyle and physical activity intervention

  • SEMC-protocol + EBS interventionTreatment being tested

    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)).

    Treatment: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)

  • Control groupNo study treatment, for comparison

    Assigned participants will receive CPAP-therapy, receive written information on healthy lifestyle but will not receive any extra support.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT06382883, who can take part
Record updated
12 August 2025