UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049924 |
|---|---|
| Receipt number | R000056862 |
| Scientific Title | Examination of usefulness of remote support application for cochlear implant |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2024/06/28 12:08:23 |
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Basic information
Public title
Examination of usefulness of remote support application for cochlear implant users
Acronym
Usefulness of remote support application for cochlear implant users
Scientific Title
Examination of usefulness of remote support application for cochlear implant
Scientific Title:Acronym
Usefulness of remote support app for cochlear implants
Region
| Japan |
Condition
Condition
After cochlear implant surgery
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cochlear implants require periodical confirmation and adjustment of hearing conditions after surgery. Therefore, regular visits to the hospital are necessary, but the visits to the hospital are a heavy burden for the wearer who lives far away or who finds it difficult to see a doctor due to reasons such as school or work. Therefore, we aim to evaluate whether the remote support application contributes to reducing the burden on patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usage experience of the remote support application (remote check), necessity of training, degree of satisfaction, points of dissatisfaction, changes in the frequency and necessity of visiting medical institutions, listening conditions/sound quality, mapping parameters, device parameters such as impedance
Key secondary outcomes
Utilization of information provided as feedback to wearers and guardians
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
We will provide participants in this study with a remote support application (remote check) that allows them to check the hearing status of their cochlear implants, and have them use the remote check for more than half a year.
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
| 4 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cochlear implant recipients who underwent cochlear implant surgery at our hospital and are using Cochlear N7 or Kanso2
Key exclusion criteria
Patients who do not agree to participate in research, patients who cannot visit the hospital regularly
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Takano |
Organization
Sapporo Medical University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
060-8556
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
kent@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Kakuki |
Organization
Sapporo Medical University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
060-8556
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
t.kakuki@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University, Hospital Clinical Research Review Committee
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056862
