The effects of “ auditory spatial training” on informational masking release with persian version of coordinate response measure(CRM) in elderly normal hearing listeners
The effects of spatial hearing training on informational masking release with Persian version of CRM in normal hearing elderly listeners
Design
A Clinical trial with a control and an intervention group design of 15 patients in each group, enrolled between February and August 2019.
Settings and conduct
To evaluate the effects of spatial hearing training, all participated will be evaluated in three phases: before spatial hearing training, during and after that at Iran University of Medical Sciences Audiology clinic.We will use the speech in noise tests and self assessment questionnaire to evaluate the training effects.
Participants/Inclusion and exclusion criteria
To evaluate the effects of spatial hearing training on informational masking release the elderly people with speech in noise perception difficulties will participate. All of the participants must have no cognition problems. For better cooperation in rehabilitation sessions only 60 to 75 year old elderly will participate.
Intervention groups
According to 5 important signs of informational masking release , the spatial hearing training is designed. These cues are: spatial separation between target and masker signals, speech in noise ratio, similarity and difference between target and masker signals, the same or different sex of target and masker signals and meaningful or non-meaningful of maskers. People will be divided in two intervention and control groups. People in control group will not receive any rehabilitation interventions.
Main outcome variables
The amount of informational masking is the main variable and SSQ score is the secondary outcome of this survey.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190118042404N1
Registration date:2019-02-25, 1397/12/06
Registration timing:registered_while_recruiting
Last update:2019-02-25, 1397/12/06
Update count:0
Registration date
2019-02-25, 1397/12/06
Registrant information
Name
Marzieh Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
amiri.ma@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of “ auditory spatial training” on informational masking release with persian version of coordinate response measure(CRM) in elderly normal hearing listeners
Public title
The effects of spatial auditory training on speech in noise perception in elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All of 60 to 75 year old people who are suffering from speech in noise perception
Exclusion criteria:
Normal hearing thresholds in 250 to 4000 Hz
No cognition impairment according to Mini mental state examination(MMSE).
High school diploma degree and upper
The age between 60 to 75 years old
Right handedness
Be Persian
Speech perception in noise difficulty
Normal middle ear function
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Near Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.303
Health conditions studied
1
Description of health condition studied
central auditory processing disorder and speech in noise perception problem
ICD-10 code
H90.5
ICD-10 code description
Unspecified sensorineural hearing loss
Primary outcomes
1
Description
Informational masking
Timepoint
Sentence correct recognition score with Persian version of Coordinate Response Measure(CRM) in three times: before the training, immediately and 1 month after that
Method of measurement
Informational masking test
Secondary outcomes
1
Description
Speech, Spatial and Qualities of Hearing Scale(SSQ) score
Timepoint
In three times: before the training and immediately and 1 month after that
Method of measurement
Measure a listener's self-reported ability to hear in a variety of everyday situations according to SSQ sub tests: speech perception, spatial hearing and quality of hearing according to a 10 degree scale
Intervention groups
1
Description
Intervention group: The people with even numbers will participate in this group. Rehabilitation sessions will be divided into some main categories: sessions with nonmeaningful competing signals such as white noise and sessions with meaningful distractive signals such as babble noise and some sentences. In all of the spatial training sessions the target signal will present from the 0 azimuth degree and the competing maskers will present from + and - 90 azimuth degree. We will use the Persian version of Quick SIN as a target signals. Every session will start from the signal to noise ratio which patient will respond correctly to less than 50 percent of sentences and will continue until 30 minutes. Training sessions will continue for 6 weeks and every week patient will participated in two sessions.
Category
Rehabilitation
2
Description
Control group: The persons with odd numbers will be in the control group. These people must not recieve any rehabilitative programs during this study. All of the particapated persons of our study are suffering from speech in noise perception, so we will guarantee that if our designed spatial traing has a significant value on the speech in noise perception we will administrate that to all of the control group persons.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Audiology clinic of Faculty of Rehabilitative of Iran University of Medical Sciences
Full name of responsible person
Marzieh Amiri
Street address
Audiology clinic, Faculty of Rehabilitative, Shah Nazari Ave, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
۱۵۸۷۵-۴۳۹۱
Phone
+98 21 2225 0541
Email
amiri.ma@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakouti
Street address
Vice chancellor for research, Vice chancellor for International Affairs,Iran University of Medical Sciences, near Milad Tower, Shahid Hemmat Highway. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Marzieh Amiri
Position
PhD student of audiology
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 8951
Email
amiri.ma@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnoush Jaroolahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdadmad Blvd
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 8051
Email
jarollahi.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marzieh Amiri
Position
PhD student of Audiology
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdadmad Blvd
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 8051
Email
amiri.ma@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available