Status Approved
First Submitted Date
2020/09/24
Registered Date
2020/10/08
Last Updated Date
2020/09/23
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005458 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 5 | |
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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 | |
Recruitment Status by Participating Study Site 1 | ||
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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Health Industry Development Institute |
Organization Type | Government |
Project ID | HC19C0128 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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
Condition(s)/Problem(s) |
* (H60-H95)Diseases of the ear and mastoid process (H90.5)Sensorineural hearing loss, unspecified Hearing Loss, Sensorineural |
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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 |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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