The effect of rehabilitation training based on temporal fine structure on speech in noise perception performance on elderly with mild to moderate hearing loss
Effect of TFS based rehabilitation training on the binaural temporal fine structure processing and speech performance in noise in elderly with mild to moderate hearing loss
Design
Clinical trial with a control group, single blind, randomized
Settings and conduct
The study population is aged 60-75 years old with mild to moderate hearing loss referring to the Audiology Clinic of the Faculty of Rehabilitation Sciences of Iran University of Medical Sciences. The statistical sample will be selected based on the inclusion criteria for entering the present study and will be divided into two groups of study and control group (which will not receive rehabilitation).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 60 to 75 years,
Mild to moderate hearing loss,
Lack of central nervous system diseases and lack of history of head trauma, epilepsy,
No use of nerves drugs,
Disturbance in Speech Noise Tests, Binaural TFS,
Being Right handed,
Acquisition lack of cognitive disorders based on the evaluation results of the MMSE cognitive status examination,
Being monolingual,
Lack of professional music experience,
Ability to collaborate on tests.
Exclusion criteria:
Unwillingness to collaborate and participate in the research project at each stage,
Inability of the individual to perform any of the tests for reasons such as insufficient focus.
Intervention groups
Intervention of rehabilitation training in the elderly with mild to moderate hearing loss
Main outcome variables
Speech in noise score in elderly people with mild to moderate hearing loss will increase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190625044006N1
Registration date:2019-08-07, 1398/05/16
Registration timing:registered_while_recruiting
Last update:2019-08-07, 1398/05/16
Update count:0
Registration date
2019-08-07, 1398/05/16
Registrant information
Name
Parisa Rasouli fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 0117
Email address
rasoulifard.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-12, 1398/04/21
Expected recruitment end date
2019-09-20, 1398/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rehabilitation training based on temporal fine structure on speech in noise perception performance on elderly with mild to moderate hearing loss
Public title
The effect of rehabilitation training on speech performance on elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 60 to 75 years
Mild to moderate hearing loss: Adaptation of the air conduction over the bone conduction, this means that the air conduction and bone conduction of the thresholds are up to 2000 Hz below 25 dB and from frequency of 2000 to 8000 Hz between 25 and 70 dB
Normal state of the middle ear (Type A tympanometry)
Lack of central nervous system diseases and lack of history of head trauma, epilepsy
No use of nerves drugs
Disturbance in speech recognition tests in noise, Binaural TFS
Right handed
Acquisition of lack of cognitive impairment based on the evaluation results of the MMSE cognitive status examination
Being monolingual
No professional music experience
Ability to collaborate on tests
Exclusion criteria:
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
0
Select eligible people according to inclusion criteria
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were kept blind in this study.
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 Science
Street address
Thirteenth floor. block A.Central Head quarters of the Ministry of Health and Medical Education. simaye Iran st.between South Falamak and Zarafshan.Ghods Town (West)
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.IUMS.REC.1398.003
Health conditions studied
1
Description of health condition studied
presbycusis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Speech in noise score
Timepoint
Before starting the study and 5 weeks later
Method of measurement
Parwin speech in noise test
Secondary outcomes
1
Description
Interaural phase difference perception
Timepoint
Before starting the study and 5 weeks later
Method of measurement
TFS_LF test
Intervention groups
1
Description
Intervention group: Elderly with mild to moderate hearing loss. Intervention type: Rehabilitation program. Program schedule: 5 weeks (3 times a week). Designed by Engineering Software and Medical Engineering Group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of rehabilitation, Iran university of medical sciences
Full name of responsible person
Parisa Rasouli fard
Street address
Faculty of rehabilitation science, Madadkaran St, Shahnazari St, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2225 0541
Email
parisa_rasouli38@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr kazem Malakooti
Street address
Iran University of Medical Sciences, West Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@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
Parisa Rasouli fard
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Madadkaran ave.,Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2227 0117
Fax
Email
rasoulifard.p@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Rasouli fard
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Madadkaran ave.,Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2227 0117
Fax
Email
rasoulifard.p@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Rasouli fard
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Madadkaran ave.,Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2227 0117
Fax
Email
rasoulifard.p@iums.ac.ir
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
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results are after rehabilitation.
When the data will become available and for how long
Get started 1 year after publishing articles and results.