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Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

K

Kuopio University Hospital

Status

Unknown

Conditions

Obstructive Sleep Apnea

Treatments

Behavioral: Lifestyle intervention (physical activity and dietary counseling)
Behavioral: General information on healthy lifestyle habits

Study type

Interventional

Funder types

Other

Identifiers

NCT00486746
KUH5551811

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Age 18-65 years
  • Apnea-hypopnea index 5-15
  • BMI 28-40

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 2 patient groups

Lifestyle intervention
Experimental group
Treatment:
Behavioral: Lifestyle intervention (physical activity and dietary counseling)
General health counseling
Active Comparator group
Treatment:
Behavioral: General information on healthy lifestyle habits

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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