Obstructive Sleep ApneaELONCT06382883
Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment
A study testing Individually tailored lifestyle and physical activity intervention and Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) in people with Obstructive Sleep Apnea, run by Filha ry at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Individually tailored lifestyle and physical activity intervention and Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 18 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A physician-diagnosed, moderate to severe obstructive sleep apnea
- BMI > 25
- Age 18- to 70-years
- No previous CPAP-treatment
Who cannot join
- 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.
- Weight-loss medication initiated less than 3 months before recruiting
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antti Saarinen contact
Finland1 site, 1 recruiting
- Recruiting
Central Finland Hospital District
Jyväskylä, 40620
Merja Perhonen, merja.perhonen@hyvaks.fi
Antti Saarinen, antti.saarinen@filha.fi
About this study
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
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Individually tailored lifestyle and physical activity intervention, Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)
- Keywords
- Obstructive Sleep Apnea, physical activity, sedentary behavior, behavioral change
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually tailored lifestyle and physical activity interventionBehavioural
Also called SEMC-protocol
Focus of the SEMC-protocol is on increasing PA gradually towards the national recommendations. Emphasis of counseling is on incidental exercise, endurance, and strength training. Techniques of motivational interviewing are utilized.
Baseline; MD+PT counseling, medical clearance, mapping lifestyle \& life situation, goal setting, measurements, questionnaires, feedback. weeks 1-6: guided group resistance training 1hr, 1x/week. 5-10-minute warm-up, 9 exercises with weight stack equipment on large muscle groups. 2-3 sets, 12-15 repetitions. Modified individually, e.g. according to musculoskeletal problems. Emphasis on learning the basics and safety aspects. After 6 weeks unsupervised training. 3-month: MD counseling and questionnaires. 6-month: MD+PT counseling, assessing safety of PA, measurements, questionnaires, feedback. 12-month: MD+PT counseling (feedback, ensuring continuity of lifestyle changes; redirecting to municipality/NGO activities), measurements, questionnaires, feedback
Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)Behavioural
Also called SEMC-protocol + EBS intervention
In addition to the SEMC-protocol, the participants will be contacted 3 times during the first 3 months (live / online as preferred). Themes:
Session 1: Motivation and illness perceptions. Exploring CPAP use, PA, and SB. Session 2: Self-regulation (feedback, goal setting, self-monitoring, action planning, problem solving), activating social support, prompts/cues, and preparatory behaviors. (Included BCTs from Michie et al 2013 taxonomy: 3.2, 12.2, 8.3,) Session 3: Assessing progress and agenda setting, self-regulation, maintenance of PA.
Measurements and questionnaires as with SEMC-protocol.
| Study group | Role | What they receive |
|---|---|---|
| SEMC-protocol | Experimental | 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). Receives: Behavioral: Individually tailored lifestyle and physical activity intervention |
| SEMC-protocol + EBS intervention | Experimental | 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)). Receives: Behavioral: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) |
| Control group | No intervention | Assigned participants will receive CPAP-therapy, receive written information on healthy lifestyle but will not receive any extra support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apnea-hypopnea-index (AHI)
Measured with sleep polygraphy (SomnoMedics), analyzed by an experienced professional according to current guidelines.
Measured: Assessed at pre-intervention, and 12 months.
Secondary outcomes (11)
Change on sleep apnea symptoms
Symptoms typically associated with OSA are measured by a questionnaire on the amount and severity of symptoms experienced during the last week prior filling the questionnaire, on a scale from 0 to 10, 0 being "not at all" and 10 "all the time". The symptoms asked are according to Finnish OSA diagnosis and treatment guidelines.
Measured: Assessed at base line, 3 months, 6 months, and 12 months.
Change in the mean daily total light physical activity time
Measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) and SENS Motion® Activity Measurement System (assessed with 7-day recordings).
Measured: Time Frame: Assessed by questionnaire at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years) and by SENS Motion® Activity Measurement System at base line and 6 months.
Change in the mean daily total moderate to vigorous (MVPA) physical activity time
Measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) and SENS Motion® Activity Measurement System (assessed with 7-day recordings).
Measured: Time Frame: Assessed by questionnaire at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years) and by SENS Motion® Activity Measurement System at base line and 6 months.
Change in the mean daily total sedentary time
Measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) and SENS Motion® Activity Measurement System (assessed with 7-day recordings). The IPAQ-SF is a concise self-assessment tool comprising 7 items designed to evaluate the duration and intensity of physical activity (PA) and sedentary behavior within individuals' daily routines over the preceding 7 days.
Measured: Time Frame: Assessed by questionnaire at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years) and by SENS Motion® Activity Measurement System at base line and 6 months.
Change in 6-minute walk distance (6MWD) in meters
Measured by 6-minute-walk test (6MWT), according to the guidelines of the American Thoracic Society (ATS).
Measured: Assessed at base line, 6 months, 12 months
Change in hand grip strength in kilograms
Measured by Saehan SH5001 hand dynamometer
Measured: Assessed at base line, 6 months, 12 months
Change in waist circumference in centimeters
Waist circumference in centimeters.
Measured: Assessed at base line, 6 months, 12 months
Change in body weight in kilograms
Weight in kilograms, measured by Bioelectrical Impedance Analysis (InBody770 body composition analyzer, Biospace Co. Ltd, Seoul, South Korea)
Measured: Assessed at base line, 6 months, 12 months
Change in visceral fat area (VFA) in square centimeters
Visceral fat area in square centimeters. Measured by Bioelectrical Impedance Analysis (InBody770 body composition analyzer, Biospace Co. Ltd, Seoul, South Korea)
Measured: Assessed at base line, 6 months, 12 months
Change in muscle mass in kilograms
Muscle mass in kilograms. Measured by Bioelectrical Impedance Analysis (InBody770 body composition analyzer, Biospace Co. Ltd, Seoul, South Korea)
Measured: Assessed at base line, 6 months, 12 months
Change in Quality of Life RAND 36-Item Health Survey
Measured by RAND-36 questionnaire. The RAND 36 questionnaire is a self-report instrument comprising 36 items designed to evaluate eight dimensions of general health status over the preceding four weeks. Responses to the questionnaire are quantified using a numeric scale ranging from 0 (minimum score) to 100 (maximum score), with higher scores indicating better health outcomes. Subsequently, these scores are expressed as a percentage of the total possible score. Items within each dimension are averaged to derive the respective scale scores. Any unanswered items (missing data) are disregarded in the computation of scale scores. Consequently, the scale scores reflect the average of all answered items within the respective dimension.
Measured: Assessed at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start18 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filha ry
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jyvaskyla, Organisation for Respiratory Health in Finland, Central Finland Hospital District
- Responsible party
- Sponsor
- Investigators
- Tuula Vasankari, Principal investigator, Filha ry (Finnish Lung Health Association)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382883
- Sponsor's protocol ID
- FINELO2024
- Acronym
- ELO
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06382883
- Acronym / sponsor ID
- ELO / FINELO2024
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, physical activity, sedentary behavior, behavioral change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Filha ryUniversity, hospital or other
- Collaborators
- University of Jyvaskyla, Organisation for Respiratory Health in Finland, Central Finland Hospital District
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEMC-protocol | Experimental | Behavioral: Individually tailored lifestyle and physical activity interventionAssigned 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). |
| SEMC-protocol + EBS intervention | Experimental | Behavioral: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)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)). |
| Control group | No intervention | –Assigned participants will receive CPAP-therapy, receive written information on healthy lifestyle but will not receive any extra support. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A physician-diagnosed, moderate to severe obstructive sleep apnea
- BMI > 25
- Age 18- to 70-years
- No previous CPAP-treatment
Key exclusion criteria (7 listed)
- 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.
- Weight-loss medication initiated less than 3 months before recruiting
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individually tailored lifestyle and physical activity interventionAlso: SEMC-protocolFocus of the SEMC-protocol is on increasing PA gradually towards the national recommendations. Emphasis of counseling is on incidental exercise, endurance, and strength training. Techniques of motivational interviewing are utilized. Baseline; MD+PT counseling, medical clearance, mapping lifestyle \& life situation, goal setting, measurements, questionnaires, feedback. weeks 1-6: guided group resistance training 1hr, 1x/week. 5-10-minute warm-up, 9 exercises with weight stack equipment on large muscle groups. 2-3 sets, 12-15 repetitions. Modified individually, e.g. according to musculoskeletal problems. Emphasis on learning the basics and safety aspects. After 6 weeks unsupervised training. 3-month: MD counseling and questionnaires. 6-month: MD+PT counseling, assessing safety of PA, measurements, questionnaires, feedback. 12-month: MD+PT counseling (feedback, ensuring continuity of lifestyle changes; redirecting to municipality/NGO activities), measurements, questionnaires, feedback | Behavioural | SEMC-protocol |
| Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)Also: SEMC-protocol + EBS interventionIn addition to the SEMC-protocol, the participants will be contacted 3 times during the first 3 months (live / online as preferred). Themes: Session 1: Motivation and illness perceptions. Exploring CPAP use, PA, and SB. Session 2: Self-regulation (feedback, goal setting, self-monitoring, action planning, problem solving), activating social support, prompts/cues, and preparatory behaviors. (Included BCTs from Michie et al 2013 taxonomy: 3.2, 12.2, 8.3,) Session 3: Assessing progress and agenda setting, self-regulation, maintenance of PA. Measurements and questionnaires as with SEMC-protocol. | Behavioural | SEMC-protocol + EBS intervention |
Primary outcome
Change in apnea-hypopnea-index (AHI)
Time frame: Assessed at pre-intervention, and 12 months.
Measured with sleep polygraphy (SomnoMedics), analyzed by an experienced professional according to current guidelines.
11 secondary outcomes
Change on sleep apnea symptoms
Time frame: Assessed at base line, 3 months, 6 months, and 12 months.
Change in the mean daily total light physical activity time
Time frame: Time Frame: Assessed by questionnaire at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years) and by SENS Motion® Activity Measurement System at base line and 6 months.
Change in the mean daily total moderate to vigorous (MVPA) physical activity time
Time frame: Time Frame: Assessed by questionnaire at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years) and by SENS Motion® Activity Measurement System at base line and 6 months.
Change in the mean daily total sedentary time
Time frame: Time Frame: Assessed by questionnaire at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years) and by SENS Motion® Activity Measurement System at base line and 6 months.
Change in 6-minute walk distance (6MWD) in meters
Time frame: Assessed at base line, 6 months, 12 months
Change in hand grip strength in kilograms
Time frame: Assessed at base line, 6 months, 12 months
Change in waist circumference in centimeters
Time frame: Assessed at base line, 6 months, 12 months
Change in body weight in kilograms
Time frame: Assessed at base line, 6 months, 12 months
Change in visceral fat area (VFA) in square centimeters
Time frame: Assessed at base line, 6 months, 12 months
Change in muscle mass in kilograms
Time frame: Assessed at base line, 6 months, 12 months
Change in Quality of Life RAND 36-Item Health Survey
Time frame: Assessed at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antti Saarinen contact
Tuula Vasankari principal investigator
Filha ry (Finnish Lung Health Association)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually tailored lifestyle and physical activity intervention and Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) in people with Obstructive Sleep Apnea, run by Filha ry at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Renkola (+358504009490, hanna.renkola@filha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea-index (AHI) (time frame: Assessed at pre-intervention, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.