Clinical trial NCT06382883: Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
physical activity
sedentary behavior
behavioral change
Lead sponsor: Filha ry
Sponsor class: OTHER
Collaborators: name: University of Jyvaskyla
name: Organisation for Respiratory Health in Finland
name: Central Finland Hospital District
First posted: 2024-04-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in apnea-hypopnea-index (AHI)
timeFrame: Assessed at pre-intervention, and 12 months.
Secondary outcomes:
measure: Change on sleep apnea symptoms
timeFrame: Assessed at base line, 3 months, 6 months, and 12 months.
measure: Change in the mean daily total light physical activity time
timeFrame: 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.
measure: Change in the mean daily total moderate to vigorous (MVPA) physical activity time
timeFrame: 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.
measure: Change in the mean daily total sedentary time
timeFrame: 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.
measure: Change in 6-minute walk distance (6MWD) in meters
timeFrame: Assessed at base line, 6 months, 12 months
measure: Change in hand grip strength in kilograms
timeFrame: Assessed at base line, 6 months, 12 months
measure: Change in waist circumference in centimeters
timeFrame: Assessed at base line, 6 months, 12 months
measure: Change in body weight in kilograms
timeFrame: Assessed at base line, 6 months, 12 months
measure: Change in visceral fat area (VFA) in square centimeters
timeFrame: Assessed at base line, 6 months, 12 months
measure: Change in muscle mass in kilograms
timeFrame: Assessed at base line, 6 months, 12 months
measure: Change in Quality of Life RAND 36-Item Health Survey
timeFrame: Assessed at base line, 3 months, 6 months, and 12 months (and 2, 3 and 5 years)
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Hospital District
Study officials:
affiliation: Filha ry (Finnish Lung Health Association)
name: Tuula Vasankari
role: PRINCIPAL_INVESTIGATOR
References: