Clinical trial NCT00486746: Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
Official title: Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
lifestyle intervention
cardiovascular
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: Finnish Institute for Health and Welfare
First posted: 2007-06-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Apnea-hypopnea index 5-15
* BMI 28-40

Primary outcomes:
measure: To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
timeFrame: 3 months
measure: To evaluate, if these favourable changes remain in follow-up.
timeFrame: 1, 2 and 5 years
Secondary outcomes:
measure: To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
timeFrame: 5 years
measure: 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
timeFrame: baseline, 3 months, 1, 2 and 5 years
measure: 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
timeFrame: 1,2,5 years
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopion University Hospital
name: Henri Tuomilehto, PhD
role: STUDY_DIRECTOR
References:
citation: Tuomilehto H, Seppa J, Uusitupa M, Tuomilehto J, Gylling H; Kuopio Sleep Apnea Group. Weight reduction and increased physical activity to prevent the progression of obstructive sleep apnea: A 4-year observational postintervention follow-up of a randomized clinical trial. [corrected]. JAMA Intern Med. 2013 May 27;173(10):929-30. doi: 10.1001/jamainternmed.2013.389. No abstract available.
citation: Lehto SM, Sahlman J, Soini EJ, Gylling H, Vanninen E, Seppa J, Viinamaki H, Tuomilehto H. The association between anxiety and the degree of illness in mild obstructive sleep apnoea. Clin Respir J. 2013 Apr;7(2):197-203. doi: 10.1111/j.1752-699X.2012.00304.x.
citation: Sahlman J, Seppa J, Herder C, Peltonen M, Peuhkurinen K, Gylling H, Vanninen E, Tukiainen H, Punnonen K, Partinen M, Uusitupa M, Tuomilehto H. Effect of weight loss on inflammation in patients with mild obstructive sleep apnea. Nutr Metab Cardiovasc Dis. 2012 Jul;22(7):583-90. doi: 10.1016/j.numecd.2010.10.007. Epub 2010 Dec 28.
citation: Tuomilehto H, Gylling H, Peltonen M, Martikainen T, Sahlman J, Kokkarinen J, Randell J, Tukiainen H, Vanninen E, Partinen M, Tuomilehto J, Uusitupa M, Seppa J; Kuopio Sleep Apnea Group. Sustained improvement in mild obstructive sleep apnea after a diet- and physical activity-based lifestyle intervention: postinterventional follow-up. Am J Clin Nutr. 2010 Oct;92(4):688-96. doi: 10.3945/ajcn.2010.29485. Epub 2010 Aug 11.
citation: Kemppainen T, Ruoppi P, Seppa J, Sahlman J, Peltonen M, Tukiainen H, Gylling H, Vanninen E, Tuomilehto H. Effect of weight reduction on rhinometric measurements in overweight patients with obstructive sleep apnea. Am J Rhinol. 2008 Jul-Aug;22(4):410-5. doi: 10.2500/ajr.2008.22.3203.