Assesment the changes of echocardiograghy- systmic BP- AHI and CRP and blood uric acid levels in patients with mild to moderate obstructive sleep apnea before and after sleep surgery.
The sleep apnea is a common disease.This disease is a transient respiratory arrest in the sleep.In our semiexperimental study the main goal is assesment of the changes in echocardiography- hypertension- AHI and the levels of CRP- blood uric acid in the patient with mild to moderate obstructive sleep apnea before and after sleep surgery.Our study is nonrandomized and without control with placcebo.The main inclusion criteria is AHI>15 or AHI<40 with severe daily somnolence.The main exclusion criteria is previous palatal surgery or head and neck radiation or facial anomaly.The sample size is 23 person and the method of surgery is Uvulopalatopharyngoplasty based on observation of significant retropalatal collapse in DISE.The primary outcome of surgery is improvment of life style due to sleep and reduction of cardiovascular accident result from sleep apnea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010831822N1
Registration date:2017-05-02, 1396/02/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-02, 1396/02/12
Registrant information
Name
Kayvan Aghazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
aghazadeh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research and technology of Tehran University Of Medical Sciences.
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2019-04-03, 1398/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment the changes of echocardiograghy- systmic BP- AHI and CRP and blood uric acid levels in patients with mild to moderate obstructive sleep apnea before and after sleep surgery.
Public title
Assesment the changes of echocardiograghy- systmic BP- AHI and CRP and blood uric acid levels in patients with mild to moderate obstructive sleep apnea before and after sleep surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: OSA basd on polysomnogaghy; the patient with OSA that candidate for sleep surgery; AHI>15 or AHI<40 with severe daily somnolence; The age between 30-65. The main exclusion criteria: previous palatal surgery; head and neck radiation; facial anomaly or craniofacial syndrome.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University Of Medical Scinces
Street address
Kshavarz boulvar. qods street.Morality organization of TUMS
City
Tehran
Postal code
Approval date
2017-01-31, 1395/11/12
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1595
Health conditions studied
1
Description of health condition studied
Obsructive sleep apnea
ICD-10 code
J30-J39
ICD-10 code description
Other diseases of upper respiratory tract
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and one month after intervention
Method of measurement
Holter monitoring
2
Description
Ejection Fraction
Timepoint
Before and one month after intervention
Method of measurement
Echocardiography
3
Description
Sleep Condition
Timepoint
Before and one month after intervention
Method of measurement
Polysomnography
Secondary outcomes
1
Description
CRP
Timepoint
Before and one month after intervention
Method of measurement
Blood sample test
2
Description
Serum uric acid
Timepoint
Before and one month after intervention
Method of measurement
Blood sample test
3
Description
BMI
Timepoint
Before and one month after intervention
Method of measurement
Proportion of height to (weight square)
Intervention groups
1
Description
Uvulopalatopharyngoplasty is the one of types of open procedure that reduces the shape and size of uvula - soft palate and pharynx and includes resection of uvula - tonsiles and the part of soft palate and oral roof and indicates for significant retropalatal collapse.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Dr Faezeh Dehsa
Street address
Tehran - saadi shomali street - Amiraalam hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for researches and technology
Full name of responsible person
Dr. Masoud Younesian
Street address
Sixth floor, Main Building, Tehran University of Medical Sciences, Kshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for researches and technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Amiraalam hospital
Full name of responsible person
Faezeh Dehsara
Position
ENT resident
Other areas of specialty/work
Street address
Amiraalam hospital, Saadi st.
City
Tehran
Postal code
Phone
+98 21667081035
Fax
Email
Farhan.Dsr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Faezah Dehsara
Position
ENT resident
Other areas of specialty/work
Street address
Amiraalam hospital, Saadi St.
City
Tehran
Postal code
Phone
+98 21 6670 8103
Fax
Email
Farhan.Dsr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mokhtari
Position
phD of physiology
Other areas of specialty/work
Street address
Amiraalam hospital, Saadi st.
City
Tehran
Postal code
Phone
+98 21 6676 0296
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)