in this study, we will use double vowels discrimination and combined auditory training program to measuring the perceptual learning in young old adults.
Design
A multi-arm randomized clinical trial with control group, random allocation using sealed envelops and outcome assessor blind. this study will be performed in a one phase on 30 people. for random allocation, group names was written on different carts and put in an envelope and We take a card for each participant
Settings and conduct
After conducting initial assessments and ensuring that inclusion criteria are met double vowel identification test and CV in noise test was evaluated, after then participants were randomly allocated to one of the 3 groups and received auditory training program for 4-12 session, after the intervention both test were evaluated again.
Participants/Inclusion and exclusion criteria
all participant with age of 65-74 years old can participate in this study with the following entry criteria: the behavioral pure-tone audiometry threshold levels of ≤40 dBHL in octave frequencies of 250–8000 Hz,right handedness, not having a remarkable cognitive problems according to MMSE (MMSE over 28), no previous formal musical training, inclination to continue the test in any of the test steps and no difficulty to understand the task
Intervention groups
during the intervention, double vowels with different Δf0 provided, participants should identify both vowels after hearing each stimulus.and Δf0 changed adaptability. in the other hand for each correct recognition answer,Δf0 decreased in 3 level and for any wrong answer Δf0 increased in 1 level.
Main outcome variables
double vowel identification score
speech perception in noise
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151005024360N4
Registration date:2021-03-03, 1399/12/13
Registration timing:prospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Akram Pourbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 0541
Email address
pourbakht.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating perceptual learning caused by combined auditory training interventions including active listening and passive hearing in young old adults.
Public title
The effect of combined auditory training program in older adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 65 and 74 years
Behavioral pure-tone audiometry threshold levels of ≤40 dBHL in octave frequencies of 250–8000 Hz
Right-handedness
No remarkable cognitive problems (MMSE over 28)
Exclusion criteria:
History of continuous participation in music education classes and professional music practice
Difficulty to understand the task or follow the instructions
Disinclination to continue the test in any of the test steps
Age
From 65 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation with sealed envelopes
first intervention group, second intervention group and control group are written on cards. These cards are placed in the envelope,
The person ( responsible for carrying out the auditory training program) picks up a card from the envelope for each client and implements the relevant auditory training program accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study, outcome assessor have no information about study groups. Actually outcome assessor is responsible for implementing the auditory training program.
Placebo
Not used
Assignment
Parallel
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 Campus, Hemmat freeway, next to Milad tower, Tehran,
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-10-28, 1399/08/07
Ethics committee reference number
IR.IUMS.REC.1399.721
Health conditions studied
1
Description of health condition studied
speech perception in noise
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
double vowel identification
Timepoint
Before and after intervention
Method of measurement
double vowel identification score
Secondary outcomes
1
Description
Speech perception in noise
Timepoint
Before and after intervntion
Method of measurement
CV in noise test
Intervention groups
1
Description
Intervention group 1: They receive a auditory training program in half of the session time, (identifying 180 trials of double vowels) and in the other half the session, participants performing a visual-spatial task (Tetris game) And during which 180 trials of double vowels will be provided via the head-phone in the background.
Category
Rehabilitation
2
Description
Intervention group 2: in this group participants performing a visual-spatial task (Tetris game) in all session time And during which 360 trials of double vowels will be provided via the head-phone in the background.
Category
Rehabilitation
3
Description
Control group: in this group listeners actually performed the routine auditory training using discrimination of 360 trail of double vowel in whole time of the session
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center on Hashtgerd county
Full name of responsible person
Tayyebe Fallahnezhad
Street address
Jomhuri Ave. No.13
City
Hashtgerd
Province
Alborz
Postal code
13487 - 15459
Phone
+98 21 2225 0541
Email
fallahnezhad.t@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevallian
Street address
near Milad Tower, Shahid Hemmat Highway. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@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
Akram Pourbakht
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Madadkaran st., Shanazari st., Mirdamad Ave
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21222250541
Fax
+98 21 2222 0946
Email
pourbakht.a@iums.ac.ir
Web page address
http://rehab.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Pourbakht
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Madadkaran st., Shanazari st., Mirdamad Ave
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21222250541
Fax
+98 21 2222 0946
Email
pourbakht.a@iums.ac.ir
Web page address
http://rehab.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tayyebe Fallahnezhad
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Faculty of Rehabilitation, Madadkaran st., Shahnazari st., Madar sq., Mirdamad
City
Tehran
Province
Tehran
Postal code
13487 - 15459
Phone
+98 21 2225 0541
Email
fallahnezhad.t@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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