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Completed

NCT Number: NCT04061226

Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Overnight polysomnography

Device

Overnight polysomnography will be performed in a sleep laboratory (EEG, EOG, EMG, ECG, respiratory movements of the chest and abdomen, oro-nasal airflow, and O2 saturation will be examined

Primary outcomes

  1. Apnea hypopnea index

    Time frame: Through study completion, an average of 1 year

    Apnea hypopnea index will be measured in both groups

Secondary outcomes

  1. Cardio Ankle Vascular Index (CAVI)

    Time frame: Through study completion, an average of 1 year

    Noninvasive arterial stiffness and vascular age index CAVI will be measured in both groups

  2. Response on ergo-spirometry test

    Time frame: Through study completion, an average of 1 year

    Cardiopulmonary exercise test parameters (oxygen consumption at peak exercise (ml/kg/min) and VE/VCO2 slope) will be measured in both groups.

  3. Ambulatory 24-hour blood pressure measurement (ABPM)

    Time frame: Through study completion, an average of 1 year

    Ambulatory 24-hour blood pressure measurement (ABPM) will be analyzed conventionally and chronobiologically in both broups

Sponsors and collaborators

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Other

Registry information

Official study title

Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea. The Role of Body Fat Distribution in the Prevalence of Obstructive Sleep Apnea.

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2019
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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