Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

NCT04061226 | Completed

• 1 other identifier: IIT-2014-21
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Body Fat Distribution

Keywords

obstructive sleep apnea, normal weight obesity

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index

  Apnea hypopnea index will be measured in both groups

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Cardio Ankle Vascular Index (CAVI)

  Through study completion, an average of 1 year

• Response on ergo-spirometry test

  Through study completion, an average of 1 year

• Ambulatory 24-hour blood pressure measurement (ABPM)

  Through study completion, an average of 1 year

Study Arms (2)

Central obesity group

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

Device: Overnight polysomnography

Without central obesity group

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

Device: Overnight polysomnography

Interventions

Overnight polysomnography 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

Central obesity group; Without central obesity group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead

Study Sites (1)

St. Anne's University Hospital

Brno, 65691, Czechia

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Pavel Homolka, M.D.,Ph.D.

  St Anne's University Hospital in Brno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 19, 2019
• Study Start: May 1, 2016
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

CZ (1)