Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00486746
• Other study ID #: KUH5551811
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2004
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: December 2021
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years

• Apnea-hypopnea index 5-15

• BMI 28-40

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Lifestyle intervention (physical activity and dietary counseling)
One-year intervention
• General information on healthy lifestyle habits
A single session

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (3)

Lead Sponsor	Collaborator
Kuopio University Hospital	National Institute for Health and Welfare, Finland, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea		3 months
Primary	To evaluate, if these favourable changes remain in follow-up.		1, 2 and 5 years
Secondary	To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea		5 years
Secondary	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
Secondary	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