Relationship Between Normal-weight Central Obesity and Ob... | NCT04061226

Studies
Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

NCT04061226

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Status

Completed

Last Update Posted

Jan 3, 2024Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Sleep Disorder
Body Fat Distribution

Interventions

Overnight polysomnography

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2016Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jul 31, 2023Actual

First Submitted Date

Aug 14, 2019

First Submission Date that Met QC Criteria

Aug 16, 2019

First Posted Date

Aug 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2024

Last Update Posted Date

Jan 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pavel Homolka, M.D.,Ph.D.	St Anne's University Hospital in Brno	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Anne's University Hospital		Brno		65691	Czechia

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided