UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054428 |
|---|---|
| Receipt number | R000062166 |
| Scientific Title | Observational study to verify the effectiveness of the medical device Relive Shirt |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/11/17 09:35:20 |
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Basic information
Public title
Observational study to verify the effectiveness of the medical device Relive Shirt
Acronym
Verification of Relive shirt
Scientific Title
Observational study to verify the effectiveness of the medical device Relive Shirt
Scientific Title:Acronym
Verification of Relive shirt
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will verify the safety of the Relive Shirt and clarify its effects on the living body and changes in physical functions, including its effects on sleep quality and circulatory and respiratory functions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Allergy incidence after 30 days
Key secondary outcomes
Total sleep time
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing Relive shirt
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who wear the Relive shirt and consent to sleep evaluation by Fitbit tracker
2) Items that do not interfere with daily activities
Key exclusion criteria
1) Those taking oral medication for sleep or mental illness due to health reasons
2) Those with skin allergies
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | TORU |
| Middle name | |
| Last name | MIZUGUCHI |
Organization
Sapporo Medical University
Division name
Department of Nursing
Zip code
0608556
Address
S1, W17, Chuo-Ku, Sapporo
TEL
0116112111
tmizu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | TORU |
| Middle name | |
| Last name | MIZUGUCHI |
Organization
Sapporo Medical University
Division name
Department of Nursing
Zip code
0608556
Address
S1, W17, Chuo-ku, Sapporo
TEL
0116112111
Homepage URL
tmizu@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical Univesity
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Ethics Committee
Address
s1, W17, Chuo-ku, Sapporo
Tel
0116112111
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The ethics committee determined that it was not acceptable for a public research institution to publish health evaluations using products that were registered as medical devices.
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062166
