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Effects of auditory binaural temporal resolution training on Franssen illusion and sound localization: interventional quasi experimental study

Protocol summary

Study aim
Effects of auditory binaural temporal resolution training on Franssen illusion and sound localization: interventional quasi experimental study
Design
Before and after Clinical trial,Elderly,16 participants
Settings and conduct
Present study includes two sub-studies. first, binaural temporal resolution rehabilitation is performed and its effect on ability of binaural temporal resolution is analyzed statistically. second, effect of changes on Franssen illusion and sound localization is studied. The present study will be conducted in the audiology clinic of Iran's Faculty of Rehabilitation. rehabilitation sessions are held 2 times a week, 45minutes each time and for 10 to 12 sessions for each person.1500 Hz tone burst with a duration of 250 milliseconds and a rise and fall time of 20 milliseconds will be used. Sounds with different ITD are presented through headphones and the person has to respond by indicating the place of perception of the sound source. Stimuli will be presented binaurally with a time difference of 700, 300, 100, 0, -100, -300 and -700 microseconds between the two ears at an intensity of 50 dBSL. Each ITD is practiced many times with the participants.
Participants/Inclusion and exclusion criteria
Age range of 60 to 75 years.Normal hearing thresholds (less than 20 dB HL) in 250 - 2000 Hz. No history of ear,balance, neurological diseases, head trauma, and psychotropic drugs and Alcohol consumption. Cognitive health (scoring between 21 to 30) based on MMSE questionnaire. Written and verbal consent to enter research.Temporal resolution threshold above 8 ms in gap in noise test.
Intervention groups
Binaural temporal resolution with ITDs 700, 300, 100, 0, -100, -300 and -700 microseconds, in elderly with normal hearing below2kHz، are performed. Each ITD is practiced many times with participants
Main outcome variables
Binaural temporal resolution ability, Franssen illusion score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220717055483N1
Registration date: 2022-10-08, 1401/07/16
Registration timing: registered_while_recruiting

Last update: 2022-10-08, 1401/07/16
Update count: 0
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
Mehri Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3740 1626
Email address
mehri.maleki.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-05, 1401/05/14
Expected recruitment end date
2022-10-21, 1401/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of auditory binaural temporal resolution training on Franssen illusion and sound localization: interventional quasi experimental study
Public title
Effects of auditory binaural temporal resolution training on sound localization
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 60 to 75 years old No history of ear, balance, neurological diseases, , head trauma, psychotropic drugs and Alcohol consumption Having perfect cognitive health (score between 21 to 30) based on MMSE questionnaire Written and verbal consent to enter research
Exclusion criteria:
Obtaining temporal resolution threshold below 8 ms in gap in noise test hearing thresholds more than 20 dB HL in 250 to 2000 Hz
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: 16
Randomization (investigator's opinion)
N/A
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
Faculty of Rehabilitation Sciences, Madadkaran Alley, Shah Nazari St, Mader Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.IUMS.REC.1400.1099

Health conditions studied

1

Description of health condition studied
Binaural temporal resolution, Auditory spatial illusions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Binaural temporal resolution
Timepoint
Before and after the end of the intervention
Method of measurement
Behavioral test to investigate Binaural temporal resolution

Secondary outcomes

1

Description
Franssen illusion score
Timepoint
Before and after the intervention
Method of measurement
Behavioral tests

Intervention groups

1

Description
Localization rehabilitation sessions are held 2 times a week, 45minutes each time and 10 to 12 sessions for each person.1500 Hz tone burst with a duration of 250 milliseconds and a rise and fall time of 20 milliseconds will be used. Sounds with different ITD are presented through headphones and the person has to respond by indicating the place of perception of the sound source. Stimuli will be presented binaurally with a time difference of 700, 300, 100, 0, -100, -300 and -700 microseconds between the two ears at an intensity of 50 dBSL. Each ITD is practiced many times with the participants so that it can be well identified and the participants has to indicate the location of the sound source
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Students of the Rehabilitation Faculty,Care Center for the Elderly, Region 3, Tehran
Full name of responsible person
Mehri Maleki
Street address
Faculty of Rehabilitation Sciences, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
کدپستی : ۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
mehri.maleki.a@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Ahadi
Street address
Faculty of Rehabilitation Sciences, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
mohsenahadi@gmail.com
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
Mohsen Ahadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Faculty of Rehabilitation Sciences, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
mohsenahadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Ahadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Faculty of Rehabilitation Sciences, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
mohsenahadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Ahadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Faculty of Rehabilitation Sciences, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
mohsenahadi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The data related to the behavioral evaluations of the participants before and after the intervention will be published
When the data will become available and for how long
Access starts from 1402
To whom data/document is available
Everyone can access the study data
Under which criteria data/document could be used
People should contact the responsible person's email to receive documents
From where data/document is obtainable
Faculty of Rehabilitation Sciences, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran mohsenahadi@gmail.com
What processes are involved for a request to access data/document
People should contact the responsible person's email to receive documents
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