Life-style Changes in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The primary aim is to study whether a tailored behavioural medicine intervention addressing physical activity and eating habits have additional effects to continuous positive airways pressure (CPAP) in patients with moderate or severe obstructive sleep apnea syndrome (OSAS) combined with obesity. Direct everyday life consequences (see below) of OSAS are studied, as well as cognitive functions and ventilatory parameters. Long-term benefits will be examined in terms of quality of life and everyday life activity. Another aim is to study mechanisms of treatment effects, if any. The specific goals are: To study changes in OSAS ventilatory parameters following a tailored behavioural medicine intervention addressing physical activity and eating habits (including CPAP) compared to regular CPAP-treatment To study immediate and long-term effects on daytime sleepiness, attention and concentration, everyday life activity, quality of life following a tailored behavioural medicine intervention addressing physical activity and eating habits (including CPAP) compared to regular CPAP-treatment To study associations of changes in metabolic parameters and systemic inflammation and physical activity level and adherence to CPAP-regimen respectively. To identify mediators, moderators, and predictors of treatment effects, if any.

Detailed Description
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OSAS is characterised by loud snoring, upper airway obstruction, and occasional apnea during sleep. OSAS may affect at least 4% of the men and 2% of the women in middle-age. In Sweden, prevalence figures of 200 000 have been reported. The mechanisms behind OSAS is not fully explained but functionally impaired upper airways muscles, causing a reduction in tonic and phasic contraction during sleep, are proposed one key explanation. The reduced contractions cause partial or complete occlusion of airflow, which in turn cause oxygen desaturation and sleep fragmentation. Patients commonly report everyday life consequences including loud snoring, sleep disturbances, daytime sleepiness, reduced alertness and concentration, and involvement in motor vehicle accidents. Between 7% and 70% of patients suffer from depression and anxiety (figures vary extensively because of methodological differences in existing studies). Due to cardiovascular consequences, OSAS is also linked to hypertension, myocardial infarction, and stroke. Approximately 75% of patients with severe OSAS carry overweight. First line measures recommended for OSAS are conservative including lifestyle modifications, CPAP, and oral appliances. Current state-of-science concludes that CPAP is best possible evidence-based treatment. Despite the use of life style modification recommendations in terms of physical activity and weight loss in accepted guidelines of OSAS, randomised clinical trials supporting these recommendations are rare. Hence, the value of health behaviour modifications has yet to be established. Research within this area is therefore of major interest and urgency, which has motivated the present study design.

Official Title
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Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.

Conditions
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Sleep Apnea, Obstructive, Obesity

Intervention / Treatment
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* Behavioral: Behavioural strategies to promote physical activity and weight loss
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe obstructive sleep apnea syndrome (AHI/DI>15) BMI>30 Literate in Swedish language Exclusion Criteria: Physically active patients (walking, bicycling for more than 30 minutes per day,during more than 5 days per week) Cardiovascular diseases including myocardial infarctions and stroke Patients on waiting list for gastric by-pass

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored behavioural treatment and CPAP<br>Tailored behavioural treatment targeting physical activity and eating habits. | Behavioral: Behavioural strategies to promote physical activity and weight loss<br>* 8-10 sessions, 2-4 booster sessions Behavioural protocol in seven steps to initiate, carry out and maintain health-enhancing physical activity and sound eating habits. Steps are standardized including: progressive goal setting, self-monitoring, functional behavioural analysis, skills training (basic and applied), generalization, and maintenance and relapse prevention. Content within each step is tailored to individual expectations and skills. Treatments are provided by a physical therapist and a dietician.<br>|
| Active Comparator: CPAP-treatment<br>CPAP-treatment as usual. Advice about benefits of physical activity and weight loss. | Device: CPAP<br>* CPAP-treatment as usual (during nights)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilatory parameters | Ventilatory monitoring at night. Oxygen saturation continuously measured by a pulse oximeter. The following parameters are analysed: desaturation index apnoea-hypnoea index average oxygen saturation during sleep minimum oxigen saturation respiration thoracic respiratory movements snoring heart rate body position | Baseline, immediate post-treatment, 18-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness | Epworths sleepiness scale | Baseline, immediate post-treatment, 18-month follow-up | 
| Attention and concentration | COWAT Repetition of figures from WAIS | Baseline, immediate post-treatment, 18-month follow-up | 
| Health-related quality of life | SF-36 | Baseline, immediate post-treatment, 18-month follow-up | 
| Patients' priorities of daily activities and participation | The Patient Goal Priority Questionnaire | Baseline, immediate post-treatment, 18-month follow-up | 
| Physical activity | Sensewear armband Physical activity diary | Baseline, immediate post-treatment, 18-month follow-up | 
| Functional physical capacity | 6 minutes walking distance | Baseline, immediate post-treatment, 18-month follow-up | 
| Eating behaviour | Dutch eating behaviour questionnaire | Baseline, immediate post-treatment, 18-month follow-up | 
| Self-efficacy and readiness to change behaviour | Exercise self-efficacy scale Self-efficacy for sound eating habits Readiness to change behaviour | Baseline, mid-treatment, immediate post-treatment, 18-month follow-up | 
| Anthropometrics | BMI Waist measurement Neck circumference | Baseline, immediate post-treatment, 18-month follow-up | 
| Depression | MADRS Depression scale | Baseline, immediate post-treatment, 18-month follow-up | 
| Fear of movement | Selected items from the Tampa Scale of Kinesiophobia | Baseline, mid-treatment, immediate post-treatment, 18-month follow-up | 
| Blood sample | CRP TNF-alfa lgF-1 Hb HbA1C s-cholesterol, HDL, LDL, s-triglycerids K, Na Creatinin, Leptin, Sysozym, n-terminal pBNP | Baseline, immediate post-treatment, 18-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Obesity, Behavioural medicine, Physical therapy, Health behaviour change, Physical activity, Eating habits