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A prospective study on the effectiveness of tinnitus retraining therapy based on mobile devices for tinnitus patients

Status Approved

First Submitted Date

2020/12/31
Registered Date

2021/01/28
Last Updated Date

2020/12/31

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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	KCT0005845
Unique Protocol ID	H-2010-144-1168
Public/Brief Title	A prospective study on the effectiveness of tinnitus retraining therapy based on mobile devices for tinnitus patients
Scientific Title	A prospective study on the effectiveness of tinnitus retraining therapy based on mobile devices for tinnitus patients
Acronym	mobile-based TRT
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	H-2010-144-1168
Approval Date	2020-12-17
Institutional Review Board Name	Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board (SNUCM/SNUH IRB)
Institutional Review Board Address	103, Daehak-ro, Jongno-gu, Seoul
Institutional Review Board Telephone	02-2072-0694
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	Moo Kyun Park
Title	Professor
Telephone	+82-2-2072-2447
Affiliation	Seoul National University Hospital
Address	101 Daehak-ro Jongno-gu, Seoul
Contact Person for Public Queries
Name	Chae Dong Yim
Title	Fellow
Telephone	+82-2-2072-2287
Affiliation	Seoul National University Hospital
Address	101 Daehak-ro Jongno-gu, Seoul
Contact Person for Updating Information
Name	Chae Dong Yim
Title	Fellow
Telephone	+82-2-2072-2287
Affiliation	Seoul National University Hospital
Address	101 Daehak-ro Jongno-gu, Seoul

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	Recruiting
Date of First Enrollment	2020-12-22 Actual
Target Number of Participant	76
Primary Completion Date
Study Completion Date
Name of Study	Seoul National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-12-22 ,

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	Seoul National University Hospital
Organization Type	Medical Institute
Project ID	H-2010-144-1168

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is conducted to compare the effect of 'Tinnitus Retraining Therapy' through direct counseling for tinnitus patients and 'Tinnitus Retraining Therapy' through untact counseling based on mobile devices to see if it is actually useful for tinnitus patients. The study was designed under the assumption that if 'Tinnitus Retraining Therapy' through direct training and 'Tinnitus Retraining Therapy' using mobile devices are noninferior in the treatment effect of tinnitus patients, direct counseling can be replaced with untact counseling using mobile devices. 'Tinnitus Retraining Therapy' is carried out by randomly assigning 38 people each to control group of the direct counseling and experimental group that implements untact counseling using mobile devices. The control group are provided counseling directly by using the 'Tinnitus Retraining Therapy' PPT file by an otolaryngologist, and the experimental group uses mobile devices saved contents of the 'Tinnitus Retraining Therapy' recorded by an otolaryngologist. After counseling, sound therapy is performed using the white noise of mobile devices as is the same as the existing method. The assessment compares the changes after one month and three months of treatment by conducting a questionnaire about the tinnitus handicap inventory (THI), VAS, anxiety scale, depression scale, and sleep quality before and after the 'Tinnitus Retraining Therapy', respectively.

Study Summary Information

Lay Summary

This study is conducted to compare the effect of &#39;Tinnitus Retraining Therapy&#39; through direct counseling for tinnitus patients and &#39;Tinnitus Retraining Therapy&#39; through untact counseling based on mobile devices to see if it is actually useful for tinnitus patients.

The study was designed under the assumption that if &#39;Tinnitus Retraining Therapy&#39; through direct training and &#39;Tinnitus Retraining Therapy&#39; using mobile devices are noninferior in the treatment effect of tinnitus patients, direct counseling can be replaced with untact counseling using mobile devices.

&#39;Tinnitus Retraining Therapy&#39; is carried out by randomly assigning 38 people each to control group of the direct counseling and experimental group that implements untact counseling using mobile devices. 
The control group are provided counseling directly by using the &#39;Tinnitus Retraining Therapy&#39; PPT file by an otolaryngologist, and the experimental group uses mobile devices saved contents of the &#39;Tinnitus Retraining Therapy&#39; recorded by an otolaryngologist. 
After counseling, sound therapy is performed using the white noise of mobile devices as is the same as the existing method.
The assessment compares the changes after one month and three months of treatment by conducting a questionnaire about the tinnitus handicap inventory (THI), VAS, anxiety scale, depression scale, and sleep quality before and after the &#39;Tinnitus Retraining Therapy&#39;, respectively.

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	Others (counseling of Tinnitus Retraining Therapy)
Intervention Description	The control group are provided the counseling directly by using the 'Tinnitus Retraining Therapy' PPT file by an otolaryngologist, and the experimental group uses mobile devices to the video contents of the 'Tinnitus Retraining Therapy' recorded by an otolaryngologist. After counseling, sound therapy is performed using the white noise of mobile devices as is the same as the existing method.
Number of Arms	2
Arm 1	Arm Label mobile-based group of Tinnitus Retraining Therapy
	Target Number of Participant 38
	Arm Type Experimental
	Arm Description The experimental group use mobile devices saved the video contents of the 'Tinnitus Retraining Therapy' recorded by an otolaryngologist.
Arm 2	Arm Label direct counseling group of Tinnitus Retraining Therapy
	Target Number of Participant 38
	Arm Type Active comparator
	Arm Description The control group are provided counseling directly by using the 'Tinnitus Retraining Therapy' PPT file by an otolaryngologist.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H93.1)Tinnitus Tinnitus
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~No Limit
	Description Patients with tinnitus for more than three months Over 20 years of age Mobile device (smartphone or tablet) users
Exclusion Criteria	Pulsatile tinnitus Patients with cognitive impairment and mental illness Who is cooperation is not possible
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	clinical-equivalence
Outcome	Tinnitus Handicap Inventory (THI)
Timepoint	3 months after TRT
Secondary Outcome(s) 1
Outcome	Visual analog scale (VAS), State-Trait Anxiety Inventory-X1 & 2, Pittsburgh Sleep Quality Index, Score of TRT satisfaction questionnaire, Tinnitogram
Timepoint	3 months after TRT

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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