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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04061226
Other study ID # IIT-2014-21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2016
Est. completion date July 31, 2023

Study information

Verified date January 2024
Source St. Anne's University Hospital Brno, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date July 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility 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)

Study Design


Intervention

Device:
Overnight polysomnography
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

Locations

Country Name City State
Czechia St. Anne's University Hospital Brno

Sponsors (1)

Lead Sponsor Collaborator
St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apnea hypopnea index Apnea hypopnea index will be measured in both groups Through study completion, an average of 1 year
Secondary Cardio Ankle Vascular Index (CAVI) Noninvasive arterial stiffness and vascular age index CAVI will be measured in both groups Through study completion, an average of 1 year
Secondary Response on ergo-spirometry test Cardiopulmonary exercise test parameters (oxygen consumption at peak exercise (ml/kg/min) and VE/VCO2 slope) will be measured in both groups. Through study completion, an average of 1 year
Secondary Ambulatory 24-hour blood pressure measurement (ABPM) Ambulatory 24-hour blood pressure measurement (ABPM) will be analyzed conventionally and chronobiologically in both broups Through study completion, an average of 1 year
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