Sleep DisorderNCT04061226
Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea
An observational study of Sleep Disorder and Body Fat Distribution, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Body Fat Distribution
- What is being tested?
- Overnight polysomnography
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2016to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group of patients with normal weight central obesity and group of patients with normal weight without central obesity.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Sleep Disorder, Body Fat Distribution
- Being tested
- Overnight polysomnography
- Keywords
- obstructive sleep apnea, normal weight obesity
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight polysomnographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Central obesity group | Normal weight central obesity patients (by BMI and WHR). Receives: Device: Overnight polysomnography | |
| Without central obesity group | Normal weight patients without central obesity (by BMI and WHR). Receives: Device: Overnight polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index
Apnea hypopnea index will be measured in both groups
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Cardio Ankle Vascular Index (CAVI)
Noninvasive arterial stiffness and vascular age index CAVI will be measured in both groups
Measured: 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.
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 May 2016
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Homolka, M.D.,Ph.D., Principal investigator, St Anne's University Hospital in Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061226
- Sponsor's protocol ID
- IIT-2014-21
- Status last verified
- Jan 2024
- First submitted
- 14 Aug 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04061226
- Acronym / sponsor ID
- IIT-2014-21
- Conditions
- Sleep Disorder, Body Fat Distribution
- Keywords
- obstructive sleep apnea, normal weight obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central obesity group | – | Device: Overnight polysomnographyNormal weight central obesity patients (by BMI and WHR). |
| Without central obesity group | – | Device: Overnight polysomnographyNormal weight patients without central obesity (by BMI and WHR). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group of patients with normal weight central obesity and group of patients with normal weight without central obesity.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overnight polysomnographyOvernight 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 | Device | Central obesity group, Without central obesity group |
Primary outcome
Apnea hypopnea index
Time frame: Through study completion, an average of 1 year
Apnea hypopnea index will be measured in both groups
3 secondary outcomes
Cardio Ankle Vascular Index (CAVI)
Time frame: Through study completion, an average of 1 year
Response on ergo-spirometry test
Time frame: Through study completion, an average of 1 year
Ambulatory 24-hour blood pressure measurement (ABPM)
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Homolka, M.D.,Ph.D. principal investigator
St Anne's University Hospital in Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Body Fat Distribution, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea index (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.