Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment

NCT06382883 | Recruiting

• 1 other identifier: FINELO2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; physical activity; sedentary behavior; behavioral change

Outcome Measures

Primary Outcomes (1)

• Change in apnea-hypopnea-index (AHI)

  Measured with sleep polygraphy (SomnoMedics), analyzed by an experienced professional according to current guidelines.

  Assessed at pre-intervention, and 12 months.

Secondary Outcomes (11)

• Change on sleep apnea symptoms

  Assessed at base line, 3 months, 6 months, and 12 months.

• Change in the mean daily total light physical activity time

  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: 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: 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

  Assessed at base line, 6 months, 12 months

Study Arms (3)

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).

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)).

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.

Interventions

Individually tailored lifestyle and physical activity intervention BEHAVIORAL

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

Also known as: SEMC-protocol

SEMC-protocol

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

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.

Also known as: SEMC-protocol + EBS intervention

SEMC-protocol + EBS intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Filha ry: lead
• University of Jyvaskyla: collaborator
• Organisation for Respiratory Health in Finland: collaborator
• Central Finland Hospital District: collaborator

Study Sites (1)

Central Finland Hospital District

Jyväskylä, 40620, Finland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior

Study Officials

• Tuula Vasankari

  Filha ry (Finnish Lung Health Association)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Renkola

CONTACT

+358504009490; hanna.renkola@filha.fi

Antti Saarinen

CONTACT

antti.saarinen@filha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 24, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)