Determination of apnea, hypopnea index changes and obstructive sleep apnea correction after bone graft in alveolar cleft patients.
Design
This study will be performed as a double blinded quasi experimental.This is a before-after interventional pilot research which would be executed on 10 alveolar cleft patients for evaluation of apnea/hypopnea index by Apnea-link device.
The person who would collect the data and also who investigate them are blind.
Settings and conduct
Oral and maxillofacial surgery department of Ghaem hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All of the patients with unilateral alveolar cleft with age range 8-15 years old who would be candidate for bone graft; BMI less than 30 kg/m2; Without congenital syndromes; Without the history of cardiovascular or respiratory diseases like rhinitis, asthma , bronchitis.
ٌٍExclusion criteria:
Patients who would not attend for follow up; graft failure (due to exposure or infection)
Intervention groups
Intervention group: bone graft for alveolar cleft treatment group.
No control group is َavailable in this study.
Main outcome variables
Apnea/hypopnea index value; postoperative obstructive sleep apnea recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022697N3
Registration date:2018-06-05, 1397/03/15
Registration timing:prospective
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Sahand Samiee rad
Name of organization / entity
mashhad dental school,oral and maxillofacial department
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 7289
Email address
samieerads@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of apnea, hypopnea index changes and obstructive sleep apnea correction after bone graft in alveolar cleft patients.
Public title
Evaluation of obstructive sleep apnea correction after bone graft in alveolar cleft patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of the patients with unilateral alveolar cleft with age range 8-15 years old who would be candidate for bone graft.
BMI less than 30 kg/m2
ASA 1,2
Without congenital syndromes
Without history of cardiovascular or respiratory diseases like rhinitis, asthma , bronchitis.
Exclusion criteria:
Graft failure (due to exposure or infection)
Patients who would not attend for follow up.
Age
From 8 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Person who would be responsible for data collection and also principle investigator and analysor are blind.
Placebo
Not used
Assignment
Single
Other design features
This study will be a quasi-experimental and pilot before-after interventional research.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mashhad university of medical sciences
Street address
Ghoreishi building, Daneshghah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.mums.sd.REC.1394.342
Health conditions studied
1
Description of health condition studied
Obstructive sleep apnea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnea
2
Description of health condition studied
Alveolar cleft
ICD-10 code
Q37
ICD-10 code description
Cleft palate with cleft lip
Primary outcomes
1
Description
Apnea & Hypopnea index value.
Timepoint
1 week before surgery and 1 month postoperatively.
Method of measurement
Apnea link device measurement.
2
Description
Sleep apnea recovery.
Timepoint
1 week before surgery and 1 month postoperatively.
Method of measurement
Apnea link device measurement and questionare.
Secondary outcomes
1
Description
Sleep quality recovery.
Timepoint
1 week before surgery and 1 month postoperatively.
Method of measurement
Sleep questionnare.
Intervention groups
1
Description
Bone graft for alveolar cleft
Category
Treatment - Surgery
2
Description
No control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Sahand samiee rad
Street address
Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Eslami
Street address
Ghoreishi building, Daneshghah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
91779448959
Phone
+98 51 3841 2081
Fax
+98 51 3841 2081
Email
eslamis@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samiee rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samiee rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial surgery
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Khoshsirat
Position
Chief resident
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
alirezakhoshsirat85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
َAll collected unindetified data would be shared for all researchers.
When the data will become available and for how long
The access to data will be started 6 months after publication.
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad).
E-mail: samieerads@mums.ac.ir
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission.