Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatments lifestyle intervention (physical activity and dietary counseling), general information on healthy lifestyle habits
Sponsor Kuopio University Hospital
Collaborator University of Eastern Finland
Start date October 2004
End date December 2007
Trial size 81 participants
Trial identifier NCT00486746, KUH5551811

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lifestyle intervention (physical activity and dietary counseling)
One-year intervention
(Active Comparator)
general information on healthy lifestyle habits
A single session

Primary Outcomes

Measure
To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea
time frame: 3 months
To evaluate, if these favourable changes remain in follow-up.
time frame: 1, 2 and 5 years

Secondary Outcomes

Measure
To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea
time frame: 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
time frame: 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
time frame: 1,2,5 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Age 18-65 years - Apnea-hypopnea index 5-15 - BMI 28-40

Additional Information

Official title Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.