Life-style Changes in Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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:

        1. 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

        2. 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

        3. To study associations of changes in metabolic parameters and systemic inflammation and
           physical activity level and adherence to CPAP-regimen respectively.

        4. To identify mediators, moderators, and predictors of treatment effects, if any.
    

Detailed description: 
      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.
    

Intervention name(s): Behavioural strategies to promote physical activity and weight loss; CPAP
Intervention type(s): Behavioral; Device
Intervention description(s): 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.; CPAP-treatment as usual (during nights)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Obesity; Behavioural medicine; Physical therapy; Health behaviour change; Physical activity; Eating habits