Effects of auditory localization training on speed processing and speech perception in elderly with difficulty in speech perception-in-noise
Design
A control clinical trial with a parallel groups, randomized using blocking on 36 elderly
Settings and conduct
After visiting Rofideh Hospital Elderly Clinic and the components of the initial hearing assessment, the P-SSQ questionnaire will be completed and the localization and Q-SIN tests will be performed. Persian version of MMSE test, speech compression test with time compression, consonant-vowel test in the presence of noise, word recognition in the presence of noise, reaction time test, electrophysiology test ALLR, then divided into two groups and for 10 to 12 sessions undergo hearing localization rehabilitation at the end of the rehabilitation period and one month after that the assessments are repeated.
Participants/Inclusion and exclusion criteria
Age range 65-75 years;Hearing range better than 25 dBHL at frequencies of 250 to 4000 Hz and symmetrical hearing in both ears ;Complaints of difficulty understanding speech in crowded environments:Score Low (less than 7) in the Persian version of the P-SSQ questionnaire; signal to noise ratio index above 7dB in the Persian version of the Q-SIN test; the normal middle ear status and the normal results of acoustic reflex and tympanometry, tympanogram Type A and static compliance from 0.3 to 1/6;Having a minimum score of 25 in the MMSE assessment; No neurological and autological disorders; No history of neurological and mental diseases ; Persian language
Intervention groups
Group A (Intervention): Elderly receiving localization rehabilitation - Group B (Control): Elderly receiving no localization rehabilitation
Main outcome variables
Improving the ability to understand speech in noise in the elderly using localization based rehabilitation; Improve speech processing speed
impairment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210220050431N1
Registration date:2021-03-21, 1400/01/01
Registration timing:prospective
Last update:2021-03-21, 1400/01/01
Update count:0
Registration date
2021-03-21, 1400/01/01
Registrant information
Name
Jafar Aghazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
jaf.aghazadeh@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Auditory Localization Training on Speed Processing and Speech Perception in Elderly with Difficulty in Speech Perception-In-Noise
Public title
Auditory Localization training
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hearing range better than 25 dBHL at frequencies from 250 to 4000 Hz and symmetrical hearing in both Ears (mean threshold difference about 5 dB)
Complaining and expressing difficulty in understanding speech in crowded environments
Low score (less than 7) in The Persian version of The .P-SSQ questionnaire
Signal to noise ratio Index (SNRLOSS) above 7 dB in the Persian version of the Q-SIN test
Normal status of the middle ear and normal results of the acoustic reflex and tympanometry, tympanogram type A and static compliance from 0.3 to 1.6
Earn a minimum of 25 Points in the MMSE evaluation
No neurological and autologic disorders
Lack of a history of neurological and mental disorders
Persian language
Age range 65 to 75 years
Exclusion criteria:
Reluctance to collaborate at any stage of research
Loss of any of the changeable input criteria
Age
From 65 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method was used for random allocation. Using the website "sealed envelope.com", the statistician designed this two-group experiment of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Blocking is usually done to balance The number of samples assigned to each of the study groups should be used. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is the same and we will have. Randomization tool also uses random allocation software (software allocation Random) that these random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. For concealment we use concealment allocation. The sample allocation ratio will be (1: 1 Allocation). Then, based on the obtained blocks, the sequence of allocation of rehabilitation exercises will be given to the patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave, Daneshjo Blvd, Evin (Velenjak)
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.USWR.REC.1398.162
Health conditions studied
1
Description of health condition studied
Speech Perception difficulty in noise
ICD-10 code
H93.2
ICD-10 code description
Other abnormal auditory perceptions
Primary outcomes
1
Description
Time compressed speech test score
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Percentage of repetition of words heard
2
Description
Word recognition score in noise
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Correct recognition of word
3
Description
Consonant-Vowel in Noise Test Score
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Percentage of Correct recognition of syllables
4
Description
Reaction time
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Using the software in milliseconds
5
Description
latency of N1-P2 wave
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Using the software in milliseconds
6
Description
Amplitude of N1-P2 wave
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Using the software in microvolts
7
Description
Interaural Time Difference
Timepoint
Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation
Method of measurement
Indicate the location of the audio source
Secondary outcomes
empty
Intervention groups
1
Description
Localization training sessions are held twice a week, for 45 minutes each time for 10 to 12 sessions per person. Two high- pass noise and low-pass noise stimuli with a cut-off point of 2 kHz, a delay of 250 milliseconds and a fall time of 20 milliseconds will be used.Sounds with different ITDs are provided through headphones, and the person must respond by indicating where the sound source is perceived. Stimulus will be offered binaurally with time differences of 880, 660, 440, 220, 0, -220, -440, -880 microseconds in the intensity of 50 dBHL. Negative and positive represent the left and right ears.Each ITD is rehearsed with the person several times to be well recognizable to the individual and the individual must indicate the location of the audio source.
Category
Rehabilitation
2
Description
Control group: No rehabilitation will be performed for the control group, but after the completion of the project, it is suggested that if desired, the same rehabilitation period be performed for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofiedeh Rehabilitation Hospital
Full name of responsible person
Dr.Saeideh Merhkian
Street address
Nemati Aly. South Salimi Ave. Andarzgou Blv.
City
Tehran
Province
Tehran
Postal code
193597347698
Phone
+98 21 2220 5326
Email
rofeideh.hospital@uswr.ac.ir
Web page address
http://rofeideh.uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamidreza Khorramkhorshid
Street address
Kodakyar Ave.Daneshjo. Blv.Evin
City
Tehran
Province
Tehran
Postal code
19585713871
Phone
+98 21 2832 7173
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Jafar Aghazadeh
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
No. 2, first Behestan Ave, Pasdaran Aly
City
Tehran
Province
Tehran
Postal code
1946863198
Phone
+98 21 2277 7567
Email
jafar_aghazadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Jafar Aghazadeh
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
NO.6, First Behestan Ave, Pasdaran Aly
City
Tehran
Province
Tehran
Postal code
1946863198
Phone
+98 21 2277 7567
Email
jafar_aghazadeh@yahho.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Jafar Aghazadeh
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
No 6, First Behestan, Pasdaran Aly.
City
Tehran
Province
Tehran
Postal code
1946863198
Phone
+98 21 2277 7867
Email
jafar_aghazadeh@yahoo.com
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
Access period starts 3 months after the results are published.
To whom data/document is available
The data of this study will be avalable to researchers working in academic and scientific institution.
Under which criteria data/document could be used
Futur analysis of the delivered date will be possible only with the coordination of the main researcher.
From where data/document is obtainable
Applicant can submit their application by sending an email to the lead researcher.
What processes are involved for a request to access data/document
The request is first submitted to the principal investigator. The data is then send to the applicant in coordination with other research colleagues and in determining the applicants purpose.