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Effect of digital hearing aids with sound therapy (sound generator) for tinnitus with hearing loss

Status Approved

First Submitted Date

2020/05/21
Registered Date

2020/07/30
Last Updated Date

2020/10/07

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005270
Unique Protocol ID	2020-0782
Public/Brief Title	Effect of digital hearing aids with sound therapy (sound generator)
Scientific Title	Effect of digital hearing aids with sound therapy (sound generator) for tinnitus with hearing loss
Acronym	HATINN
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-0782
Approval Date	2020-05-18
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jong Woo Jung
Title	Professor
Telephone	+82-2-3010-3718
Affiliation	Asan Medical Center
Address	86 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea 05505
Contact Person for Public Queries
Name	Yehree Kim
Title	Clinical Fellow
Telephone	+82-2-3010-0036
Affiliation	Asan Medical Center
Address	86 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea 05505
Contact Person for Updating Information
Name	Yehree Kim
Title	Clinical Fellow
Telephone	+82-2-3010-0036
Affiliation	Asan Medical Center
Address	86 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea 05505

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-08-03 Anticipated
Target Number of Participant	40
Primary Completion Date	2022-12-31 , Anticipated
Study Completion Date	2022-12-31 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-08-03 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Asan Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study primarily aims to validate the effect of sound generators on alleviation of tinnitus. Our secondary aim is to check the effect of sound generation on hearing aid performance. In the control group, we will prescribe RIC type hearing aid and the patients will use the hearing aid for 7 months. In the experimental group, we will prescribe RIC type hearing aid with Zen program and the patients will use the program for 7 months. Tinnitogram, tinnitus handicap inventory, pure tone audiometry, speech detection test, impedance audiometry, hearing in noise test will be performed at 1,4,7 months after hearing aid use.

Study Summary Information

Lay Summary

This study primarily aims to validate the effect of sound generators on alleviation of tinnitus. Our secondary aim is to check the effect of sound generation on hearing aid performance.
In the control group, we will prescribe RIC type hearing aid and the patients will use the hearing aid for 7 months. In the experimental group, we will prescribe RIC type hearing aid with Zen program and the patients will use the program for 7 months.
Tinnitogram, tinnitus handicap inventory, pure tone audiometry, speech detection test, impedance audiometry, hearing in noise test will be performed at 1,4,7 months after hearing aid use.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	1. Experimental group : Prescribe RIC type hearing aid with Zen program 2. Control : Prescribe RIC type hearing aid
Number of Arms	2
Arm 1	Arm Label Sound generator
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Prescribe RIC type hearing aid with Zen program and use the program for 7 months.
Arm 2	Arm Label Hearing aid
	Target Number of Participant 20
	Arm Type Active comparator
	Arm Description Prescribe RIC type hearing aid and use the hearing aid for 7 months.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H90.5)Sensorineural hearing loss, unspecified Sensorineural hearing loss, tinnitus
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~64Year
	Description 1. Patients over the age of 19 and below 65 2. Patients with unilateral tinnitus and unilateral/bilateral sensorineural hearing loss that has lasted longer than 3 months 3. Patients with continuous tinnitus 4. Sensorineural hearing loss patients with a speech discrimination score better than 50%
Exclusion Criteria	1. Patients with a history of middle ear diseases or surgery that may prohibit the use of hearing aids 2. Patients with hyperacusis 3. Patients with pulsatile tinnitus 4. Patients with Meniere's disease, CPA tumor, superior canal dehiscence syndrome, otitis media 5. Patients with cognitive impiarment (dementia, Alzheimer's diseas)
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Tinnitogram, tinnitus handicap inventory
Timepoint	1,4,7 months after hearing aid use
Secondary Outcome(s) 1
Outcome	Pure tone audiometry, speech detection test, impedance audiometry, hearing in noise test
Timepoint	1,4,7 months after hearing aid use

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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