Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

Completed

• Conditions: Body Fat Distribution; Sleep Disorder
• Interventions: Device: Overnight polysomnography

• Registration Number: NCT04061226
• Lead Sponsor: St. Anne's University Hospital Brno, Czech Republic

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central obesity group	Overnight polysomnography	Normal weight central obesity patients (by BMI and WHR).
Without central obesity group	Overnight polysomnography	Normal weight patients without central obesity (by BMI and WHR).

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea index	Through study completion, an average of 1 year	Apnea hypopnea index will be measured in both groups

Secondary Outcome Measures

Name	Time	Method
Response on ergo-spirometry test	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.
Cardio Ankle Vascular Index (CAVI)	Through study completion, an average of 1 year	Noninvasive arterial stiffness and vascular age index CAVI will be measured in both groups
Ambulatory 24-hour blood pressure measurement (ABPM)	Through study completion, an average of 1 year	Ambulatory 24-hour blood pressure measurement (ABPM) will be analyzed conventionally and chronobiologically in both broups

Trial Locations

Locations (1)

St. Anne's University Hospital; 🇨🇿 Brno, Czechia