Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Lifestyle intervention (physical activity and dietary counseling); Behavioral: General information on healthy lifestyle habits

• Registration Number: NCT00486746
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Primary Completion: 2007-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Lifestyle intervention (physical activity and dietary counseling)	-
General health counseling	General information on healthy lifestyle habits	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland