Obstructive Sleep Apnea
Conditions
Keywords
sleep apnea, lifestyle intervention, cardiovascular
Brief summary
The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.
Detailed description
Obstructive sleep apnea (OSA) is one of the most common sleep disturbances, and it has been estimated that one out of five adults has at least some degree of sleep related breathing disturbances. Obstructive sleep apnea affects mostly the middle-aged work force, and causes a negative impact on public health by increasing both morbidity and mortality. Obesity is related to many diseases including diabetes, cardiovascular diseases, and metabolic syndrome,and obesity is also considered as the most important risk factor for OSA.Considering the prevalence of mild OSA, and the beneficial effects of even a slight weight loss on both the severity of OSA and the likelihood of developing OSA, lifestyle intervention including weight reduction represents a viable option for the treatment of patients with mild OSA.However, although included in the clinical guidelines, there is a definite lack of well executed studies on the effect of weight reduction upon OSA. Accordingly, we are conducting a randomized study on the effects of lifestyle intervention in the most prevalent subgroup of OSA patients, overweight patients with mild OSA. The study is an on-going prospective, randomized, parallel group trial. The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.
Interventions
BEHAVIORALLifestyle intervention (physical activity and dietary counseling)
One-year intervention
BEHAVIORALGeneral information on healthy lifestyle habits
A single session
Sponsors
University of Eastern Finland
Finnish Institute for Health and Welfare
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Apnea-hypopnea index 5-15 * BMI 28-40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea | 3 months |
| To evaluate, if these favourable changes remain in follow-up. | 1, 2 and 5 years |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea | 5 years |
| To evaluate, whether the mild OSA has detrimental effects on cardiovascular functions and glucose-, insulin- and lipid metabolisms, regulation of autonomous nervous system, endothelial function, baroreflex sensitivity | baseline, 3 months, 1, 2 and 5 years |
| To evaluate, if improvement of mild OSA has beneficial influence on quality of life, cardiovascular functions and glucose-, insulin- and lipid metabolisms, regulation of autonomous nervous system, endothelial function, and anatomy of the pharynx | 1,2,5 years |
Countries
Finland
Outcome results
None listed