The Effects of Dynamic Spatial Hearing Rehabilitation Combined with Transcranial Electrical Stimulation on Speech Perception in Noise in Elderly Men with Normal Hearing
Determining The Effects of Dynamic Spatial Hearing Rehabilitation Combined with Transcranial Electrical Stimulation on Speech Perception in Noise in Elderly Men with Normal Hearing
Design
4 groups
Sample size: 80
Randomization: assign to four equal groups with a Quadruple random blocks method.
Phase: no applicable
Settings and conduct
Dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home
For tDSC, the direct current which increases from a 0.5 mA intensity gradually to 2 mA (9 v), is presenting by a pair of carbon-rubber electrodes with a diameter of 21 mm and an area of 3.5 cm² dissolved in salt water, anode/right-cathod/left on the superior temporal gyrus area including planum temporale and auditory cortex (T7 and T8 regions according to the electrodes method 10-20) in three months (In the first two weeks, four sessions a week and then a weekly session), and each session will be presented 20 minutes
Location: Audiology clinic, School of Rehabilitation, Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Elderly men aged between 60-75 years with normal hearing and speech perception difficulty.
Intervention groups
1. dynamic spatial hearing rehabilitation (DSHR)
2. DSHR and tDCS
3. Control
4. Sham
Main outcome variables
signal to noise ratio loss index (SNR Loss)
Spatial Release from Masking index
The total and subscale scores of the SSQ questionnaire
P1, N1, P2 latencies
N1-P2 amplitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160131026279N2
Registration date:2019-03-07, 1397/12/16
Registration timing:registered_while_recruiting
Last update:2019-03-07, 1397/12/16
Update count:0
Registration date
2019-03-07, 1397/12/16
Registrant information
Name
Mansoureh Adel Ghahraman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 4364
Email address
madel@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-04, 1397/12/13
Expected recruitment end date
2019-09-04, 1398/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Dynamic Spatial Hearing Rehabilitation Combined with Transcranial Electrical Stimulation on Speech Perception in Noise in Elderly Men with Normal Hearing
Public title
Rehabilitation and tDCS in geriatric speech perception
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly men aged between 60-75 years .
The average thresholds of frequencies of 500, 1000, 2000 Hz are less than or equal to25 dB HL in both ears, and the thresholds of each of the higher frequencies alone are less than or equal to 40 dB HL (31) and the auditory symmetry in both ears (mean difference of threshold About dB 5 HL).
Normal middle ear: Type A Tympanogram and Static Compailance between 0.3 and 1.6
Right handedness (based on Edinburgh Handedness Inventory)
Farsi language and Monolingual
Lack of cognitive problems (obtaining a minimum score of 21 out of 30 Mini–Mental State Examination (MMSE)
having problem of speech perception in noisy environments based on the participant’s statement
No pacemaker due to interference with electrical stimulation
Lack of norologic disease.
Lack of uncontrolled high blood pressure or diabetes
Exclusion criteria:
Normal results of all evaluations and tests used in this study before any intervention
Reluctant to continue cooperation in research
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random assign to four equal groups with a Quadruple random blocks method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2018-04-15, 1397/01/26
Ethics committee reference number
IR.TUMS.FNM.REC.1397.073
Health conditions studied
1
Description of health condition studied
Auditory processing disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
signal to noise ratio loss index (SNR Loss)
Timepoint
Before, immediately after completing intervention, and one month after the completion of intervention
Method of measurement
Quick Speech in Noise (QSIN) Test
2
Description
Spatial Release from Masking index
Timepoint
Before, immediately after completing intervention, and one month after the completion of intervention
Method of measurement
Binaural Masking Level Difference Test (BMLD)
3
Description
The total and subscales score of the SSQ questionnaire
Timepoint
Before, immediately after completing intervention, and one month after the completion of intervention
Method of measurement
Persian version of speech, spatial and qualities of hearing scale (SSQ)
4
Description
P1, N1, P2 latencies
Timepoint
Before, immediately after completing intervention, and one month after the completion of intervention
Method of measurement
Recording auditory late latency responses (LLR)
5
Description
N1-P2 amplitude
Timepoint
Before, immediately after completing intervention, and one month after the completion of intervention
Method of measurement
Recording auditory late latency responses (LLR)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receiving dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home
Category
Rehabilitation
2
Description
Intervention group 2: receiving dynamic spatial hearing rehabilitation and tDCS. Dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home. For tDSC, the direct current which increases from a 0.5 mA intensity gradually to 2 mA (9 v), is presenting by a pair of carbon-rubber electrodes with a diameter of 21 mm and an area of 3.5 cm² dissolved in salt water, anode/right-cathod/left on the superior temporal gyrus area including planum temporale and auditory cortex (T7 and T8 regions according to the electrodes method 10-20) in three months (In the first two weeks, four sessions a week and then a weekly session), and each session will be presented 20 minutes.
Category
Rehabilitation
3
Description
Control group: no intervention
Category
Rehabilitation
4
Description
Sham group: not receiving spatial hearing rehabilitation and is placed in the tDCS sessions of the electrode, but no electrical stimulation is applied.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Audiology clinic, School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 0636
Email
madel@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shabnam Noroozzadeh
Street address
Tehran University of Medical Sciences (TUMS), Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3627
Email
research@tums.ac.ir
Grant name
Annual funding, School of Rehabilitation
Grant code / Reference number
97-02-32-38674
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.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
No more information
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Reporting as a PhD dissertation and papers
When the data will become available and for how long
2019 and after
To whom data/document is available
All
Under which criteria data/document could be used
In accordance with Tehran University of Medical Sciences copyright
From where data/document is obtainable
ِDatabases for papers
Library of the School of Rehabilitation, TUMS, for dissertation
What processes are involved for a request to access data/document
For papers depends on the journal's policy
For the dissertation, studying in the library