Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Eastern Finland
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00486746
First received: June 14, 2007
Last updated: September 10, 2013
Last verified: September 2013

June 14, 2007
September 10, 2013
October 2004
December 2007   (final data collection date for primary outcome measure)
  • 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, if weight reduction and lifestyle intervention improve the symptoms of mild sleep apnoea [ Time Frame: 3 months ]
  • To evaluate, if these favourable changes remain in follow-up. [ Time Frame: 1, 2 and 5 years ]
Complete list of historical versions of study NCT00486746 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate, whether the treatment of mild obstructive sleep apnoea prevents the development of diseases associated with obstructive sleep apnoea. [ Time Frame: 5 years ]
  • To evaluate, if improvement of mild sleep apnoea has beneficial influence on cardiovascular functions and glucose-, insulin- and lipid metabolisms. [ Time Frame: 3 months, 1, 2 and 5 years ]
Not Provided
Not Provided
 
Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea
Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
  • Behavioral: Lifestyle intervention (physical activity and dietary counseling)
    One-year intervention
  • Behavioral: General information on healthy lifestyle habits
    A single session
  • Experimental: Lifestyle intervention
    Intervention: Behavioral: Lifestyle intervention (physical activity and dietary counseling)
  • Active Comparator: General health counseling
    Intervention: Behavioral: General information on healthy lifestyle habits

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
Not Provided
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-65 years
  • Apnea-hypopnea index 5-15
  • BMI 28-40
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00486746
KUH5551811
No
Juha Seppa, Kuopio University Hospital
Kuopio University Hospital
  • University of Eastern Finland
  • National Institute for Health and Welfare, Finland
Study Director: Henri Tuomilehto, PhD Kuopion University Hospital
Kuopio University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP