Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

NCT ID: NCT04061226

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2023-07-31

Brief 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.

Detailed 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.

Conditions

Sleep Disorder; Body Fat Distribution

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Central obesity group

Normal weight central obesity patients (by BMI and WHR).

Overnight polysomnography

Intervention Type: 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

Without central obesity group

Normal weight patients without central obesity (by BMI and WHR).

Overnight polysomnography

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel Homolka, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St Anne's University Hospital in Brno

Locations

St. Anne's University Hospital

Brno, , Czechia

Countries

Czechia

Other Identifiers

IIT-2014-21

Identifier Type: -

Identifier Source: org_study_id