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Trial registered on ANZCTR


Registration number
ACTRN12616001389493
Ethics application status
Approved
Date submitted
2/09/2016
Date registered
6/10/2016
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association of epicardial fat thickness with clinical and polysomnographic parameters in non-obese obstructive sleep apnea (OSA) patients
Scientific title
Association of epicardial fat thickness with clinical and polysomnographic parameters in non-obese OSA patients
Secondary ID [1] 290085 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea syndrome 300171 0
Epicardial fat thickness 300238 0
Condition category
Condition code
Cardiovascular 300061 300061 0 0
Other cardiovascular diseases
Respiratory 300109 300109 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants attend a sleep laboratory for a single night of assessment, during which polysomnography is carried out involving the attachment of sensors to the head and face to assess sleep parameters. Echocardiography is then performed the following morning, which involves holding a small ultrasound device against the chest
Intervention code [1] 295824 0
Not applicable
Comparator / control treatment
This case-control study included 62 patients diagnosed with OSAS, and 22 healthy controls. Polysomnography (Include such paramaters; apnea-hypopnea index, oxygen desaturation index) and ecocardiography were performed to all participants (study and control group) to analyze sleep apnea degree and investigation of epicardial fat tickness. Assessment performed only once at enrolment.
Control group
Active

Outcomes
Primary outcome [1] 299527 0
Epicardial fat thickness, assessed by Standard transthoracic echocardiography. Standard views, including the left lateral decubitus and supine positions were obtained. Epicardial fat was defined as the relatively echo-free space between the outer wall of the myocardium and the visceral layer of the pericardium. EFT was measured in end diastole on the free wall of the right ventricle from the parasternal long- and short-axis views, as previously described. The maximum values at any site were measured, and the average value was calculated.
Timepoint [1] 299527 0
Single assessment for all paticipants.
Secondary outcome [1] 327456 0
Oxygen desaturation index was assessed from polysomnographic examination. The oxygen desaturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. It is believed that an elevation in ODI may lead to increased oxidative stress in the body that may predispose people to long-term cardiovascular risks, including high blood pressure (hypertension), heart attack, stroke, and memory loss associated with dementia.
Timepoint [1] 327456 0
Single assessment at baseline.

Eligibility
Key inclusion criteria
The patients with an apnea-hypopnea index (AHI) <5 were regarded as the controls, the ones with an AHI >5 were included in the study group, and two groups were compared for EFT. Also, all participants have one of the sleep disordered breathing symptoms such as snoring, apnea and daytime sleepiness.
Minimum age
19 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients and control groups with BMI more than 30, the ones with hypo/hyperthyroidism, primary heart disease, chronic obstructive or restrictive pulmonary disease, uncontrolled hypertension, craniofacial abnormalities, as well as the smokers and the ones that used hypnotic drugs were excluded.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8183 0
Turkey
State/province [1] 8183 0

Funding & Sponsors
Funding source category [1] 294454 0
Hospital
Name [1] 294454 0
Mugla Sitki Kocman University Training and Research Hospital
Address [1] 294454 0
Orhaniye District, Ismet Catak street 22/18, Mentese/ Mugla/Turkey, 48000
Country [1] 294454 0
Turkey
Primary sponsor type
Individual
Name
Sabri Koseoglu
Address
Mugla Sitki Kocman University, School of Medicine. Haluk Ozsoy street, No:4, Mentese, Mugla, 48000
Country
Turkey
Secondary sponsor category [1] 293366 0
None
Name [1] 293366 0
Address [1] 293366 0
Country [1] 293366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295889 0
Mugla Sitki Kocman University Clinic Investigations Ethics Committee
Ethics committee address [1] 295889 0
Haluk Ozsoy Street, Mentese, Mugla, 48000

Ethics committee country [1] 295889 0
Turkey
Date submitted for ethics approval [1] 295889 0
09/09/2014
Approval date [1] 295889 0
23/09/2014
Ethics approval number [1] 295889 0
10/3

Summary
Brief summary
Thick epicardial fat is a cardiovascular risk factor, and it has been shown to be correlated with obstructive sleep apnea (OSA), coronary artery disease, obesity, metabolic syndrome, and diabetes mellitus. In this study, we aimed to investigate the relation of epicardial fat thickness (EFT) with severity of OSA, clinical and polysomnographic parameters, and to determine independent predictors for EFT. A total of 84 patients with a body mass index <30, and suspected sleep disordered breathing were included in the study. Their EFT were measured using echocardiography. The patients with an apnea-hypopnea index (AHI) <5 were regarded as the controls, the ones with an AHI >5 were included in the study group, and two groups were compared for EFT. The correlations of EFT with polysomnographic and clinical data, and severity of OSA were investigated. A multivariate regression analysis was performed to determine independent predictors for EFT. There were 62 and 22 patients in study and control groups, respectively. Mean EFT was 3.75 +/- 1.07 mm in study, and 2.97 +/- 0.62 mm in the control groups (p<0.001). There was a significant positive correlation of EFT with AHI, oxygen desaturation index 3 (ODI3), and the minimum oxygen saturation as well as with age, body mass index, and neck and waist circumferences. Epicardial fat was significantly thicker in severe OSA patients. ODI3 was an independent predictor for EFT. Non-obese OSA patients have thicker epicardial fat when compared to the controls. ODI3 has a strong correlation with EFT, and it is an independent predictor for it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68814 0
A/Prof Sabri Koseoglu
Address 68814 0
Mugla Sitki Kocman University, School of Medicine. Haluk Ozsoy street, No:4, Mentese, Mugla, 48000

Country 68814 0
Turkey
Phone 68814 0
+902522115159
Fax 68814 0
Email 68814 0
drskoseoglu@gmail.com
Contact person for public queries
Name 68815 0
A/Prof Serhan Derin
Address 68815 0
Mugla Sitki Kocman University, School of Medicine. Haluk Ozsoy street, No:4, Mentese, Mugla, 48000
Country 68815 0
Turkey
Phone 68815 0
+902522115159
Fax 68815 0
Email 68815 0
drskoseoglu@gmail.com
Contact person for scientific queries
Name 68816 0
Prof Murat Sahan
Address 68816 0
Mugla Sitki Kocman University, School of Medicine. Haluk Ozsoy street, No:4, Mentese, Mugla, 48000
Country 68816 0
Turkey
Phone 68816 0
+902522115159
Fax 68816 0
Email 68816 0
dr.msahan@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary