UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052754 |
|---|---|
| Receipt number | R000060196 |
| Scientific Title | Prospective study of proper hearing aid fitting |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/10 12:09:23 |
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Basic information
Public title
Research on proper hearing aid adjustment
Acronym
HA fitting study
Scientific Title
Prospective study of proper hearing aid fitting
Scientific Title:Acronym
HA fitting study
Region
| Japan |
Condition
Condition
sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficient hearing aid fitting methods, adjust hearing aids so that the functional gain is 1/3 gain and investigate whether proper fitting has been achieved.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The hearing aids will be auditioned for two weeks, and the effectiveness of hearing aid fitting will be evaluated based on sound field testing (hearing aid fitting threshold and speech intelligibility) to determine whether appropriate hearing aid fitting was achieved.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Based on the results of the most recent pure tone audiogram, the patient is fitted with a hearing aid set up using the prescription formula (DSL version 5) and the threshold is measured in the sound field. From the results of the pure tone audiometry test, determine the 1/3 gain and calculate the difference from the functional gain at 250, 500, 1000, and 2000 Hz, respectively. Perform a hearing test using a hearing aid with gain values adjusted so that this difference is zero.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hearing loss who visit the Hearing Aid Outpatient Clinic, Department of Otolaryngology, Kitasato University Hospital and meet the following criteria
(1) Age 18 years or older.
2) The type of hearing loss is sensorineural hearing loss, and the degree of hearing loss is between 30 dBHL and 70 dBHL in average hearing acuity in both ears.
(3) Patients who are undergoing hearing aid fitting for the first time.
Key exclusion criteria
(1) Patients who seem to have difficulty in wearing hearing aids stably
(2) Patients with a history of surgery on the hearing aid wearing ear
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nitta |
| Middle name | |
| Last name | Yoshihirio |
Organization
Kitasato University School of medicine
Division name
Otolaryngology Head and Neck Surgery
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
n-yoshihiro@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Nitta |
| Middle name | |
| Last name | Yosihihiro |
Organization
Kitasato University School of medicine
Division name
Otolaryngology Head and Neck Surgery
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
Homepage URL
n-yoshihiro@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-8111
rinri@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060196
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
