Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061226
• Other study ID #: IIT-2014-21
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Body Fat Distribution
• Obesity
• Obesity, Abdominal
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders

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