Trial Review

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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
Sex
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
30/09/2014
Date of last participant enrolment
Anticipated
Actual
23/04/2015
Date of last data collection
Anticipated
Actual
23/04/2015
Sample size
Target
84
Accrual to date
Final
84
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
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
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
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
[email protected]
Contact person for public queries
Name 68815 0
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
[email protected]
Contact person for scientific queries
Name 68816 0
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.