The aim of this study is to determine the effects of low power laser on improving the smell of patients with post traumatic anosmia/hyposmia. This is an interventional study with control group. Statistical population includes all patients with anosmia/hyposmia due to trauma, who are referred to the Ear, Throat and Nose Research Center of Rasoule Akram Hospital. inclusion criteria including age between the ages of 20 to 45, and having post traumatic anosmia/hyposmia and exclusion criteria including congenital anomalies (Kalman Syndrome), single, having neurological diseases such as Parkinson's and Alzheimer's, Diabetes, smoking, sinonasal disease, acute nose disease such as infection and pregnancy. The sample size is 60 in the intervention group and 60 in the control group. Patients are examined by sniffin sticks two times: once at the entering to study and once two month after beginning the intervention. This test examines the odor threshold, odor discrimination and odor identification. The intervention will take 3 weeks during the study so that the intervention group during this period will be treated with a 1 watt 800 nm laser beam for three session (10 minutes once a week) and ultimately the effect of olfactory training on improvement of olfactory and sexual satisfaction will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017073035386N1
Registration date:2017-10-10, 1396/07/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-10, 1396/07/18
Registrant information
Name
Mohamad Farhadi
Name of organization / entity
Research Center of the ear, throat, nose and head and neck of Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 2828
Email address
farhadi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ear, nose and throat, and head and neck Research Center of Iran University of Medical Sciences and Health Services
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low power laser on the improvement of olfactory disorder in patients with anosmia/hyposmia
Public title
The effect of low power laser on the improvement of olfactory disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between the ages of 20 to 45; having post traumatic anosmia/hyposmia. Exclusion criteria: congenital anosmia(Kalman Syndrome); single; having neurological diseases such as Parkinson's and Alzheimer's; Diabetes; smoking; sinonasal disease; severe deviation of nasal blade; acute nasal disease such as infection; pregnancy.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rasoule Akram Hospital ENT research center, Iran University of Medical Sciences
Street address
2nd Floor of Building No.2, Rasoule Akram Hospital, Niayesh St., Sattarkhan Ave. Tehran
City
Tehran
Postal code
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
IR.IUMS.REC 1396.31049
Health conditions studied
1
Description of health condition studied
Post traumatic Anosmia/Hyposmia
ICD-10 code
T90-T98
ICD-10 code description
Sequelae of injuries, of poisoning and of other consequences of external causes
Primary outcomes
1
Description
Olfaction
Timepoint
at the start of study, two month after beggining of intervention
Method of measurement
Sniffin sticks tests
Secondary outcomes
empty
Intervention groups
1
Description
The control group will be left without any intervention.
Category
N/A
2
Description
The intervention group will take laser treatment for three weeks(1 session per week). These patients undergo a 10 minute session with 800 nm and 1 watts laser to repair the scar cells in the epithelial area.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoule AKram Hospital, ENT research center, Iran University of Medical Sciences