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
  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

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Apnea-hypopnea index 5-15
  • BMI 28-40
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486746

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
National Institute for Health and Welfare, Finland
Investigators
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: September 10, 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 July 28, 2014