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Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

S

St. Anne's University Hospital Brno, Czech Republic

Status

Completed

Conditions

Sleep Disorder
Body Fat Distribution

Treatments

Device: Overnight polysomnography

Study type

Observational

Funder types

Other

Identifiers

NCT04061226
IIT-2014-21

Details and patient eligibility

About

Comparison of the prevalence of obstructive sleep apnea (OSA), measured by polysomnography in normal weight patients with central obesity by body mass index (BMI) and waist hip ratio (WHR), with normal weight patients without central obesity by BMI and WHR.

Evaluation of arterial stiffness and vascular age in normal weight patients with central obesity and in normal weight patients without central obesity.

Determination of the exercise response characteristics in OSA patients.

Full description

Body composition (the distribution of adipose tissue) appears to be a risk factor for the prevalence of obstructive form of sleep apnea. The investigators expect a higher prevalence of this serious sleep pathology in normal weight patients with central obesity than in normal weight patient without central obesity. In normal weight patients with central obesity also endothelial dysfunctions, abnormal exercise response to dynamic load and abnormal circadian patterns of blood pressure and heart rate can be expected. There are theoretical assumptions for this hypothesis but relevant studies on sufficiently large samples of patients have not been done. The investigators will also compare the lipid profile in normal weight patients with central obesity with those of normal weight patients without central obesity.

Enrollment

87 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria central obesity group:

  • BMI 18.5 - 24.9 kg/m2 for both men and women
  • WHR more than 0.9 for men and 0.85 for women
  • no history of myocardial infarction, stroke, atrial fibrillation, previous diagnosis of OSA or its treatment.

Inclusion Criteria without central obesity group:

  • BMI 18.5 - 24.9 kg/m2 for men and women
  • WHR selected from the lowest tertile of WHR distribution for both men and women

Exclusion Criteria:

  • acute infection
  • known diagnosis of chronic renal or cardiac failure
  • taking drugs that affect sleep (stimulants, hypnotics, antidepressants, antipsychotics, anxiolytics, antihistamines, corticosteroids, theophylline, anti-parkinsonic drugs, anticonvulsants, morphine-type analgetics)

Trial design

87 participants in 2 patient groups

Central obesity group
Description:
Normal weight central obesity patients (by BMI and WHR).
Treatment:
Device: Overnight polysomnography
Without central obesity group
Description:
Normal weight patients without central obesity (by BMI and WHR).
Treatment:
Device: Overnight polysomnography

Trial contacts and locations

1

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Central trial contact

Pavel Homolka, M.D., Ph.D.; Libuse Martinakova, Bc.

Data sourced from clinicaltrials.gov

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