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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04061226
Enrollment
87
Registered
2019-08-19
Start date
2016-05-01
Completion date
2023-07-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Fat Distribution, Sleep Disorder

Keywords

obstructive sleep apnea, normal weight obesity

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.

Interventions

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

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Apnea hypopnea indexThrough study completion, an average of 1 yearApnea hypopnea index will be measured in both groups

Secondary

MeasureTime frameDescription
Cardio Ankle Vascular Index (CAVI)Through study completion, an average of 1 yearNoninvasive arterial stiffness and vascular age index CAVI will be measured in both groups
Response on ergo-spirometry testThrough study completion, an average of 1 yearCardiopulmonary exercise test parameters (oxygen consumption at peak exercise (ml/kg/min) and VE/VCO2 slope) will be measured in both groups.
Ambulatory 24-hour blood pressure measurement (ABPM)Through study completion, an average of 1 yearAmbulatory 24-hour blood pressure measurement (ABPM) will be analyzed conventionally and chronobiologically in both broups

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026