Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea |
Behavioral: Lifestyle intervention (physical activity and dietary counseling) Behavioral: General information on healthy lifestyle habits |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea |
- To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- To evaluate, if these favourable changes remain in follow-up. [ Time Frame: 1, 2 and 5 years ] [ Designated as safety issue: No ]
- To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 81 |
| Study Start Date: | October 2004 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lifestyle intervention |
Behavioral: Lifestyle intervention (physical activity and dietary counseling)
One-year intervention
|
| Active Comparator: General health counseling |
Behavioral: General information on healthy lifestyle habits
A single session
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-65 years
- Apnea-hypopnea index 5-15
- BMI 28-40
Contacts and Locations| Finland | |
| Kuopio University Hospital | |
| Kuopio, Finland, 70211 | |
| Study Director: | Henri Tuomilehto, PhD | Kuopion University Hospital |
More Information
No publications provided by Kuopio University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Juha Seppa, PhD, Kuopio University Hospital |
| ClinicalTrials.gov Identifier: | NCT00486746 History of Changes |
| Other Study ID Numbers: | KUH5551811 |
| Study First Received: | June 14, 2007 |
| Last Updated: | January 9, 2013 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Kuopio University Hospital:
|
sleep apnea lifestyle intervention cardiovascular |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013