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Positive airway pressure (PAP) therapy and its impact on the components of metabolic syndrome in obstructive sleep apnea (OSA) patients

Protocol summary

Summary
Objectives: The effect of positive airway pressure (PAP) therapy on the components of metabolic syndrome in obstructive sleep apnea (OSA) Design: The study population consists of patients with clinical indication for PAP therapy. The sample is 40 patients of Sleep Clinic in Baharlooo Hospital. This study does not have a control group. Setting and conduct: The patients referred to the Sleep Clinic complete the related questionnaires. After history taking and physical exam, a polysomnography will be performed. Patients with clinical indication for PAP therapy will be admitted to participate in the study and will be reevaluated in 3 months. Participants: Inclusion criteria consist of adult patients with OSA and clinical indication for PAP therapy. Exclusion criteria consist of pregnancy, cardiopulmonary disorder, upper airway cancer or surgery, change or new administration of drug for hyperlipidemia, hypertension and diabetes mellitus. Intervention: PAP therapy Main outcome measures: blood pressure, abdominal circumference and other anthropometric indexes, sex, age, fasting blood sugar (FBS), high density lipoprotein (HDL), triglyceride, liver and kidney tests, 25 hydroxy vitamin D3, Erythrocyte sedimentation rate (ESR), c reactive protein (CRP), and other complementary tests

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012832249N1
Registration date: 2017-04-10, 1396/01/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Zahra Banafsheh Alemohammad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5567 7333
Email address
alemohammadz@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Grant from Tehran University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Positive airway pressure (PAP) therapy and its impact on the components of metabolic syndrome in obstructive sleep apnea (OSA) patients
Public title
The effect of positive airway pressure (PAP) therapy on the components of metabolic syndrome in obstructive sleep apnea (OSA)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consist of adult patients with OSA and clinical indication for PAP therapy. Exclusion criteria consist of pregnancy, cardiopulmonary disorder, upper airway cancer or surgery, change or new administration of drug for hyperlipidemia, hypertension and diabetes mellitus.
Age
From 14 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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 Sciences
Street address
Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1549

Health conditions studied

1

Description of health condition studied
Obstructive Sleep Apnea
ICD-10 code
G47.3
ICD-10 code description
A disorder characterized by cessation of breathing for short periods during sleep

Primary outcomes

1

Description
Blood pressure
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
Sphygomanometer

2

Description
high density lipoprotein
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
Direct Enzymatic Colorimetric Method

3

Description
fasting blood sugar
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
glucose oxidase assay

4

Description
triglyceride
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
lipase peroxidase colorometric

5

Description
Abdominal Circumference
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
Metre

Secondary outcomes

1

Description
weight
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
scale

2

Description
Body Mass Index
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
scale and stadiometer

3

Description
c reactive protein
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
quantitative latex immunoturbidimetric assay

4

Description
Erythrocyte sedimentation rate
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
the Westergren method (therma)

5

Description
alkaline phosphatase
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
nitrophenyl phosphate kinetic

6

Description
complete blood count
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
cell counter

7

Description
hemoglobin A1c
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
High Performance Liquid Chromatography

8

Description
alanine amino transferase
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
NADH Kinetic UV

9

Description
aspartate amino tranferase
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
NADH Kinetic UV

10

Description
uric acid
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
enzymatic colorimetric

11

Description
cholesterol
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
cholestrol oxidase peroxidase colorimetric

12

Description
25 hydroxy vitamin D3
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
High Performance Liquid Chromatography

13

Description
creatinine
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
jaffe kinetic colorimetric

14

Description
blood urea nitrogen
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
Urease GLDH Kinetic

15

Description
low density lipoprotein
Timepoint
before treatment and 3 months following beginning of the treatment
Method of measurement
Direct Enzymatic colorimetric

Intervention groups

1

Description
PAP therapy
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Sleep Clinic of Baharloo Hospital
Full name of responsible person
Mohammad Mehraban
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masuod Yoonesian
Street address
sixth floor, Tehran University of Medical Sciences, Ghods Ave., Keshavarz 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 research, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehraban
Position
Occupational Medicine Resident
Other areas of specialty/work
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran
Postal code
Phone
+98 21 5567 7333
Fax
Email
dr_m_mehraban@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
Zahra Banafsheh Alemohammad
Position
Sleep Medicine Fellowship
Other areas of specialty/work
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran
Postal code
Phone
+98 21 5567 7333
Fax
Email
alemohammadz@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Banafsheh Alemohammad
Position
Sleep Medicine Fellowship
Other areas of specialty/work
Street address
Baharloo hospital, Behdari St., Rahahan Sq.
City
Tehran
Postal code
Phone
+98 21 5567 7333
Fax
Email
alemohammadz@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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