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Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486746
First Posted: June 15, 2007
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Eastern Finland
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Juha Seppa, 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 ]
  • To evaluate, if these favourable changes remain in follow-up. [ Time Frame: 1, 2 and 5 years ]

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 ]
  • 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 ]

Enrollment: 81
Study Start Date: October 2004
Estimated Study Completion Date: December 2017
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Apnea-hypopnea index 5-15
  • BMI 28-40
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 14, 2007
First Posted: June 15, 2007
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Juha Seppa, 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 Wake Disorders
Nervous System Diseases