Investigating the effect of auditory attention training in noise on speech recognition ability in noise of adults with sensorineural hearing loss
Design
Randomized clinical trial with control group, parallel group trial
Settings and conduct
Place of research: Audiology clinic of Razmju moghadam rehabilitation Center, Zahedan University of Medical Sciences
The present study will be conducted on 20 adults with sensorineural hearing loss . After obtaining written consent, a complete history will be taken from the participants to ensure that all the criteria for entering the research are met. In the intervention group, auditory training are presented in the form of monosyllabic words in the presence of noise binaurally at different signal-to-noise ratios. Auditory training will be done in the intervention group for 8 sessions (One session every 4 days and each session is 40 minutes). In the control group, no intervention will be done, and like the intervention group, word in noise and speech in noise tests will be done before the intervention group exercises and after the end of the eighth session
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age range from 20 to 50 years
Normal function of middle ear
Right handedness
Persian monolingual
Symmetrical moderate to moderate to severe hearing loss in both ear
Non-inclusion criteria
History of ear surgery, Head trauma, neurological disease
Suffering from cognitive disorders
Having central auditory processing disorder
Intervention groups
In the intervention group, auditory stimuli will be presented in the form of monosyllabic words in the presence of noise with different signal-to-noise ratios. Training will be done for 8 sessions and each session will be 40 minutes. The control group does not receive any intervention.
Main outcome variables
speech recognition in noise ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240130060866N1
Registration date:2024-03-08, 1402/12/18
Registration timing:prospective
Last update:2024-03-08, 1402/12/18
Update count:0
Registration date
2024-03-08, 1402/12/18
Registrant information
Name
zahra sharafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5836
Email address
za.sharafi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Selective Auditory Attention Training in Noise on Speech Recognition Ability in Noise of Adults with Sensorineural Hearing Loss
Public title
The effect of Selective Auditory Attention Training in Noise on Speech Recognition Ability in Noise
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 20 to 50 years
Normal function of middle ear
Right handed ness based on Edinburg questionnaire
Persian monolingual
Symmetrical moderate to moderate to severe hearing loss in both ear
Exclusion criteria:
History of ear surgery
History of head trauma
History of neurological disease
Suffering from cognitive problems based on the brief examination of cognitive status
Having central auditory processing disorder
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment, we will use 10 cards for group A and 10 cards for group B. The cards are placed in 20 envelopes of the same shape that are not clear inside and are numbered with numbers 1 to 20. When each participant enters, an envelope is opened and the patient group is determined.
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
Research Ethics Committees of Zahedan University of Medical Sciences
Street address
Khalij Fars Blvd, Zahedan University of Medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.ZAUMS.REC.1402.413
Health conditions studied
1
Description of health condition studied
Hearing loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral
Primary outcomes
1
Description
Speech recognition in noise ability
Timepoint
Before intervention and after intervention
Method of measurement
Word in noise and speech in noise tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Selective auditory attention training in noise
Category
Rehabilitation
2
Description
Control group: Does not receive intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razmju moghadam rehabilitation center
Full name of responsible person
Zahra Sharafi
Street address
Audiology clinic, Razmju moghadam rehabilitation center, Kafami St, after Mustafa Khomeini intersection, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3323 8383
Email
za.sharafi@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Sharafi
Street address
Khalij Fars BLVD, Zahedan University of Medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3323 8383
Email
za.sharafi@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Sharafi
Position
Instructor of Audioligy
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology clinic, Razmju moghadam rehabilitation center, Kafami St, after Mustafa Khomeini intersection, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3323 8383
Email
za.sharafi@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Sharafi
Position
Instructor of Audiology
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology clinic, Razmju moghadam rehabilitation center, Kafami St, after Mustafa Khomeini intersection, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3323 8383
Email
za.sharafi@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Sharafi
Position
Instructor of Audiology
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology clinic, Razmju moghadam rehabilitation center, Kafami St, after Mustafa Khomeini intersection, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3323 8383
Email
za.sharafi@zaums.ac.ir
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
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