Abstract:
Disorders are usually related with sleep apnea in patients with cardiovascular problems.
Objectives: To determine the effect of continuous positive pressure ventilation on left ventricular diastolic function in patients with obstructive sleep apnea is. Design: This study is a clinical trial.
Material and Method: In this study, 32 patients with concurrently obstructive sleep apnea and left ventricular diastolic dysfunction
Inclusion criteria: echocardiographic evidence of left ventricular diastolic function disorder; Patients who used continuous positive pressure ventilation for at least an hour to be endured; During the four weeks before starting treatment, the patient does not any changes in the clinical comorbidity.
During the four weeks prior to treatment, there is no change in the patient's medications; Young and middle-aged adults.
Exclusion criteria: patients who are symptomatic obstructive sleep apnea; Morbid obesity, pregnant or breast feeding women; subjects who had severe heart disease during the past three months; Use less than 3/30 hours of continuous positive pressure ventilation during the night; During the six-month period of treatment, the patient is given a change in medication; Will be Checked by random sampling.
Interventions: based on the results of polysomnography and echocardiography of patients underwent a six-month period conditioning continuous positive pressure fall and after completion of the course of treatment again two groups, before and after 6 months of diastolic function of the left ventricle echocardiography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030622134N3
Registration date:2016-06-04, 1395/03/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
Registrant information
Name
Mahtab Keshvari
Name of organization / entity
Cardiovascular Institution
Country
Iran (Islamic Republic of)
Phone
+98 913 781 0322
Email address
mkeshvari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shahrekord University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of CPAP on Diastolic function in patients with obstructive sleep apnea in Esfahan in the year 1394
Public title
The effect of continuous ventilation on left ventricular function in patients with obstructive sleep apnea in Isfahan
Purpose
Treatment
Inclusion/Exclusion criteria
Disorders are usually related with sleep apnea in patients with cardiovascular problems.
Objectives: To determine the effect of continuous positive pressure ventilation on left ventricular diastolic function in patients with obstructive sleep apnea is. Design: This study is a clinical trial.
Material and Method: In this study, 32 patients with concurrently obstructive sleep apnea and left ventricular diastolic dysfunction
Inclusion criteria: echocardiographic evidence of left ventricular diastolic function disorder; Patients who used continuous positive pressure ventilation for at least an hour to be endured; During the four weeks before starting treatment, the patient does not any changes in the clinical comorbidity.
During the four weeks prior to treatment, there is no change in the patient's medications; Young and middle-aged adults.
Exclusion criteria: patients who are symptomatic obstructive sleep apnea; Morbid obesity, pregnant or breast feeding women; subjects who had severe heart disease during the past three months; Use less than 3/30 hours of continuous positive pressure ventilation during the night; During the six-month period of treatment, the patient is given a change in medication; Will be Checked by random sampling.
Interventions: based on the results of polysomnography and echocardiography of patients underwent a six-month period conditioning continuous positive pressure fall and after completion of the course of treatment again groups, before and after 6 months of diastolic function of the left ventricle echocardiography
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave., Azadi sqr., Isfahan University of medical science, Isfahan, Iran
City
Isfahan
Postal code
009831
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.MUI.RC. 1394. 394959
Health conditions studied
1
Description of health condition studied
cardiovascular disease
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular accident NOS
2
Description of health condition studied
apnoea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnoea
Primary outcomes
1
Description
Peak E
Timepoint
6 Months after treatment with continuous positive pressure ventilation
Method of measurement
Based on the grading echocardiography
2
Description
Peak A
Timepoint
6 Months after treatment with continuous positive pressure ventilation
Method of measurement
Based on the grading echocardiography
3
Description
E/A Parameter
Timepoint
6 Months after treatment with continuous positive pressure ventilation
Method of measurement
Based on the grading echocardiography
4
Description
Flow propagation velocity
Timepoint
6 Months after treatment with continuous positive pressure ventilation
Method of measurement
Based on the grading echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Patients will be treated for for six months with continuous positive pressure conditioning