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Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00486746
Recruitment Status : Active, not recruiting
First Posted : June 15, 2007
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
University of Eastern Finland
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Lifestyle intervention (physical activity and dietary counseling) Behavioral: General information on healthy lifestyle habits Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : December 2007
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To evaluate, if weight reduction and lifestyle intervention improve the symptoms of mild obstructive sleep apnoea [ Time Frame: 3 months ]
  2. To evaluate, if these favourable changes remain in follow-up. [ Time Frame: 1, 2 and 5 years ]

Secondary Outcome Measures :
  1. To evaluate, whether the treatment of mild OSA prevents the development of diseases in general associated with sleep apnoea [ Time Frame: 5 years ]
  2. 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 ]
  3. 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 ]


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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

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

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 Posted: June 15, 2007    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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