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Clinical effectiveness of personal sound amplification products and smartphone-based hearing aid applications in adults with mild-to-moderate sensorineural hearing loss

Status Approved

First Submitted Date

2020/09/24
Registered Date

2020/10/08
Last Updated Date

2020/09/23

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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	KCT0005458
Unique Protocol ID	D-2003-028-1109
Public/Brief Title	Effectiveness of smartphone applications of hearing aids and personal sound amplifications products
Scientific Title	Clinical effectiveness of personal sound amplification products and smartphone-based hearing aid applications in adults with mild-to-moderate sensorineural hearing loss
Acronym	ESA-PSA
MFDS Regulated Study	No
IND/IDE Protocol
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	D-2003-028-1109
Approval Date	2020-06-01
Institutional Review Board Name	Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board (SNUCM/SNUH IRB)
Institutional Review Board Address	101, Daehak-ro, Jongno-gu, Seoul
Institutional Review Board Telephone	02-2072-0694
Data Monitoring Committee	Yes Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board (SNUCM/SNUH IRB)

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	Miseung Koo
Title	Researcher
Telephone	+82-2-3668-7380
Affiliation	Seoul National University Hospital
Address	101 Daehak-ro Jongno-gu, Seoul
Contact Person for Updating Information
Name	Miseung Koo
Title	Researcher
Telephone	+82-2-3668-7380
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	Multi-center Number of center : 5
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-08-27 Actual
Target Number of Participant	300
Primary Completion Date	2022-08-19 , Anticipated
Study Completion Date	2022-08-31 , Anticipated
Name of Study	Seoul National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-08-27 ,
Recruitment Status by Participating Study Site 2
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-26 ,
Recruitment Status by Participating Study Site 3
Name of Study	Koera University Guro Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-26 ,
Recruitment Status by Participating Study Site 4
Name of Study	Samsung Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-26 ,
Recruitment Status by Participating Study Site 5
Name of Study	Chungnam National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-26 ,

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	Korea Health Industry Development Institute
Organization Type	Government
Project ID	HC19C0128

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	ㅁ Purpose: To evaluate effectiveness of personal sound amplification products (PSAP) and/or mobile hearing aid apps in hearing-impaired listeners with mild-to-moderate hearing loss. This crossover study is single-blind, randomized controlled with two study arms (PSAP/hearing aid apps and a conventional hearing aid). ㅁ Hypothesis: In those with mild-to-moderate hearing loss, hearing benefit from digital hearing healthcare products (PSAP/mobile hearing aid app) would not be inferior to that from the conventional treatment (hearing aids). ㅁ Subject and Method: A multi-center single-blind randomized controlled trial among 300 patients with mild-to-moderate hearing loss. ▶This study comprises two arms: an intervention group (Arm A) and a control group (Arm B). Arm A will use a PSAP/mobile hearing aid app during the first 2 months and then standard care during the next 2 months using a conventional hearing aid; Arm B will receive standard care during the first 2 months and then use a PSAP/mobile hearing aid app during the next 2 months. The following tests will be performed on all participants in the study. ▶ For screening purpose, patients will undergo otoscopy, tympanometry, and pure-tone and speech audiometry. ▶ Subjective questionnaire ▶ Objective testing performed before and after 2 months of hearing aid use or PSAP/hearing aid app use 1) Functional gain using a loudspeaker at 0 degree azimuth, hearing-in-noise test (HINT), sound field testing 2) Real-ear measurement 3) Differences in HINT results between the 2 months use of each device will be compared.

Study Summary Information

Lay Summary

ㅁ Purpose: To evaluate effectiveness of personal sound amplification products (PSAP) and/or mobile hearing aid apps in hearing-impaired listeners with mild-to-moderate hearing loss. This crossover study is single-blind, randomized controlled with two study arms (PSAP/hearing aid apps and a conventional hearing aid).

ㅁ Hypothesis: In those with mild-to-moderate hearing loss, hearing benefit from digital hearing healthcare products (PSAP/mobile hearing aid app) would not be inferior to that from the conventional treatment (hearing aids).

ㅁ Subject and Method: A multi-center single-blind randomized controlled trial among 300 patients with mild-to-moderate hearing loss. 
▶This study comprises two arms: an intervention group (Arm A) and a control group (Arm B). Arm A will use a PSAP/mobile hearing aid app during the first 2 months and then standard care during the next 2 months using a conventional hearing aid; Arm B will receive standard care during the first 2 months and then use a PSAP/mobile hearing aid app during the next 2 months.
The following tests will be performed on all participants in the study. 
▶ For screening purpose, patients will undergo otoscopy, tympanometry, and pure-tone and speech audiometry. 
▶ Subjective questionnaire
▶ Objective testing performed before and after 2 months of hearing aid use or PSAP/hearing aid app use
  1) Functional gain using a loudspeaker at 0 degree azimuth, hearing-in-noise test (HINT), sound field testing
  2) Real-ear measurement 
  3) Differences in HINT results between the 2 months use of each device will be compared.

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	Others (Clinical effectiveness of personal sound amplification products and smartphone-based hearing aid applications in adults with mild-tomoderate sensorineural hearing loss)
Phase	Not applicable
Intervention Model	Cross-over
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Medical Device, Others (Mobile hearing aid apps, Personal Sound Amplification Products)
Intervention Description	This study comprises two arms: an intervention group (Arm A) and a control group (Arm B). Arm A will use a PSAP/mobile hearing aid app during the first 2 months and then standard care during the next 2 months using a conventional hearing aid; Arm B will receive standard care during the first 2 months and then use a PSAP/mobile hearing aid app during the next 2 months. No washout period between crossover will be applied.
Number of Arms	2
Arm 1	Arm Label Treatment group (Arm A)
	Target Number of Participant 150
	Arm Type Experimental
	Arm Description Arm A will use a PSAP/mobile hearing aid app during the first 2 months and then standard care during the next 2 months using a conventional hearing aid.
Arm 2	Arm Label Control group (Arm A)
	Target Number of Participant 150
	Arm Type Active comparator
	Arm Description Arm B will receive standard care (a conventional hearing aid) during the first 2 months and then use a PSAP/mobile hearing aid app during the next 2 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 Hearing Loss, Sensorineural
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~No Limit
	Description (1) Fluent Korean with no mental and physical disabilities and adults older than 20 years old (2) Person with a mild-to-moderate hearing loss whose pure-tone average at four frequencies of 0.5, 1, 2, 4 kHz is between 25 and 55 dB HL (3) Person without neurological disease, learning and speech disabilities
Exclusion Criteria	(1) Person with communication disability and/or difficulty in the use of digital devices (2) Person with auditory system impairment and/or central nervous system impairment (3) Person with malingering of hearing loss (4) Person who will have the potential benefits of research participation
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	Difference in hearing-in-noise test outcomes
Timepoint	Before and after 2 months of device use
Secondary Outcome(s) 1
Outcome	Improvement in functional gain and sound-field testing outcomes
Timepoint	Before and after 2 months of device 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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