Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
February 19, 2020 updated by: Juha Seppa, Kuopio University Hospital
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kuopio, Finland, 70211
- Kuopio University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-65 years
- Apnea-hypopnea index 5-15
- BMI 28-40
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Lifestyle intervention
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One-year intervention
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Active Comparator: General health counseling
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A single session
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
Time Frame: 3 months
|
3 months
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To evaluate, if these favourable changes remain in follow-up.
Time Frame: 1, 2 and 5 years
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1, 2 and 5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
Time Frame: 5 years
|
5 years
|
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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
Time Frame: baseline, 3 months, 1, 2 and 5 years
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baseline, 3 months, 1, 2 and 5 years
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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
Time Frame: 1,2,5 years
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1,2,5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Henri Tuomilehto, PhD, Kuopion University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: JAMA Intern Med. 2013 Jun 10;173(11):996.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2004
Primary Completion (Actual)
December 1, 2007
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
June 14, 2007
First Submitted That Met QC Criteria
June 14, 2007
First Posted (Estimate)
June 15, 2007
Study Record Updates
Last Update Posted (Actual)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 19, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH5551811
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