Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

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

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Body Fat Distribution
• Intervention / Treatment: Device: Overnight polysomnography

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 Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

• Study Contact: Name: Pavel Homolka, M.D., Ph.D.; Phone Number: 00420543182991; Email: pavel.homolka@fnusa.cz
• Study Contact Backup: Name: Libuse Martinakova, Bc.; Phone Number: 00420604227115; Email: libuse.martinakova@fnusa.cz

Study Locations

• Czechia
  • Brno, Czechia, 65691
    • St. Anne's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Group of patients with normal weight central obesity and group of patients with normal weight without central obesity.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Central obesity group; Normal weight central obesity patients (by BMI and WHR).	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
Without central obesity group; Normal weight patients without central obesity (by BMI and WHR).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea hypopnea index	Apnea hypopnea index will be measured in both groups	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: St. Anne's University Hospital Brno, Czech Republic
• Investigators: Principal Investigator: Pavel Homolka, M.D.,Ph.D., St Anne's University Hospital in Brno

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: obstructive sleep apnea, normal weight obesity
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obesity; Sleep Wake Disorders; Obesity, Abdominal
• Other Study ID Numbers: IIT-2014-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No