Protocol summary

Summary
In this study, 50 patients who had inclusion criteria were selected from patients suffering mild to average OSAS who referred to sleep clinic of Mashhad Ibn-Sina hospital. After explaining the objectives of the research and obtaining patients conscious consent to cooperate, they were included in the study. Patients were divided into two intervention and control groups using blocking random sampling. All patients received initial examination and medical records including photography, radiography, and waxing records. Then impression from mandible and maxilla was done with Alginate material from Materials-Kohler-Germany. In intervention group a record of jaws relation was taken while the patient was protruding lower jaw and in the next step, Essix clear device was made by Biostar machine according to patient's cast in the laboratory. Afterward, the Mandibular Advancement Splint was prepared based on the record of jaws. In order to prepare oral device, plate 3A and cold cure acrylic resin Acropars_Marlik-Iran were used. Control group also used placebo (oral device without jaw protrusion). Then for each patient in intervention group, pharyngeal MRI and pharyngeal volumetric were done twice, immediately with and without device. Since no pharyngeal anatomic changes happened by placebo, MRI was not performed in control group. After using devices by patients, daily sleepiness and sleep quality were evaluated by questionnaires at the beginning and one month after using the device. At last the results, MRI volumetric and possible side effects were compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071618509N1
Registration date: 2015-07-06, 1394/04/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Mina sadat Mohajerzadeh Heidari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2544
Email address
mohajerzadehm921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology affairs of Mashhad University of Medical Sciences (MUMS)
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2016-01-02, 1394/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mandibular Advancement Splint in comparison with Sham device on apnea hypopnea index in mild to moderate obstructive sleep apnea
Public title
Oral device for treatment of obstructive sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age more than 18 years, Willing to participate in the study, Having mild to moderate obstructive sleep apnea (Apnea Hypopnoea Index of 5 to 30), Having enough marginal dental adaptation Exclusion criteria: Having Periodontal or other kind of oral cavity disease, Having contraindication for cephalometry (such as pregnancy), Having Advanced temporomandibular joint disease, Having contraindication for body MRI
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In order to matching intervention and control groups, we used Strata method. In this way man and woman Strata are used. Because most of the patients are middle –aged, age Strata not defined. Then control and intervention group allocated accidentally.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences.
Street address
Ghoreishi Building , Daneshgah St.
City
Mashhad
Postal code
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
922805-10/08/1393

Health conditions studied

1

Description of health condition studied
obstructive sleep apnea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnoea

Primary outcomes

1

Description
Apnea Hypopnea Index per hours during sleep
Timepoint
before intervention and 1 month after intervention
Method of measurement
polysomnography

Secondary outcomes

1

Description
Oropharyngeal volumetry
Timepoint
at the beginning, with and without Mandibular Advancement Splint in interventional group
Method of measurement
Oropharyngeal MRI

2

Description
sleep quality and daytime sleepiness
Timepoint
before intervention and 1 month after intervention in interventional and control groups
Method of measurement
sleep quality questionnaire

Intervention groups

1

Description
Using advanced mandible splint with jaw protrusion in intervention group so that a record of jaws relation is taken while the patient is protruding lower jaw and in the next step Essix clear device is made by Biostar machine according to patient's cast in the laboratory. Afterward, the Mandibular Advancement Splint is prepared based on the record of jaws. In order to prepare oral device, plate 3A and cold cure acrylic resin Acropars_Marlik-Iran are used.
Category
Treatment - Devices

2

Description
placebo device (oral device without jaw protrusion) in control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad chronic obstructive pulmonary disease research center
Full name of responsible person
Mahnaz Amini
Street address
Mashhad University of Medical Science
City
Mashhad

2

Recruitment center
Name of recruitment center
Ebn -e- Sina Hospital Sleep Clinic
Full name of responsible person
Hadi Asadpour
Street address
City
Mashhad

3

Recruitment center
Name of recruitment center
Mashhad Radiology research center
Full name of responsible person
Behrooz Zandi
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreyshi Building , Daneshgah St.
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahnaz Amini
Position
Assistant Professor , Internal Medicine Specialist , Pulmonary and Critical Care Subspecialist
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3859 8818
Fax
Email
aminim@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahnaz Amini
Position
Assistant Professor ,Internal Medicine Specialist Pulmonary and Critical Care Subspecialist
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3859 8818
Fax
Email
aminim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mina Sadat Mohajerzadeh Heidari
Position
MD, Radiology resident
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3859 8818
Fax
Email
mohajerzadem921@mums.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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