Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lifestyle intervention (physical activity and dietary counseling)
General information on healthy lifestyle habits
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, lifestyle intervention, cardiovascular
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years
- Apnea-hypopnea index 5-15
- BMI 28-40
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle intervention
General health counseling
Arm Description
Outcomes
Primary Outcome Measures
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
To evaluate, if these favourable changes remain in follow-up.
Secondary Outcome Measures
To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
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
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
Full Information
NCT ID
NCT00486746
First Posted
June 14, 2007
Last Updated
February 19, 2020
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, Finnish Institute for Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT00486746
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (Actual)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, Finnish Institute for Health and Welfare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, lifestyle intervention, cardiovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Title
General health counseling
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention (physical activity and dietary counseling)
Intervention Description
One-year intervention
Intervention Type
Behavioral
Intervention Name(s)
General information on healthy lifestyle habits
Intervention Description
A single session
Primary Outcome Measure Information:
Title
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
Time Frame
3 months
Title
To evaluate, if these favourable changes remain in follow-up.
Time Frame
1, 2 and 5 years
Secondary Outcome Measure Information:
Title
To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
Time Frame
5 years
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years
Apnea-hypopnea index 5-15
BMI 28-40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri Tuomilehto, PhD
Organizational Affiliation
Kuopion University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23589169
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. Erratum In: JAMA Intern Med. 2013 Jun 10;173(11):996.
Results Reference
derived
PubMed Identifier
22686135
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.
Results Reference
derived
PubMed Identifier
21193295
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.
Results Reference
derived
PubMed Identifier
20702607
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.
Results Reference
derived
PubMed Identifier
18702908
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.
Results Reference
derived
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Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
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