UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043119 |
|---|---|
| Receipt number | R000049225 |
| Scientific Title | Evaluation of wearable devices by comparing with PSG |
| Date of disclosure of the study information | 2021/01/28 |
| Last modified on | 2024/07/29 11:59:56 |
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Basic information
Public title
Evaluation of wearable devices by comparing with PSG
Acronym
Evaluation of wearable devices
Scientific Title
Evaluation of wearable devices by comparing with PSG
Scientific Title:Acronym
Evaluation of wearable devices
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the accuracy of wearable devices and confirm whether they can detect SpO2 drop events precisely.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SpO2
Key secondary outcomes
Heart late, Sleep depth
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear wearable devices during the PSG test, up to 10 hours.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with PSG test.
Patietns who can agree with informed consent forms.
Key exclusion criteria
Patients who cannot wear wearable devices.
Patietns who cannot agree with informed consent forms.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kammei |
| Middle name | |
| Last name | Rai |
Organization
Okayama University Hospital
Division name
Allergy and Respiratory medicine (Hospital-based cancer registry division)
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-Ku, Okayama city, Okayama, 7008558, Japan
TEL
086-235-7227
rai@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kammei |
| Middle name | |
| Last name | Rai |
Organization
Okayama University Hospital
Division name
Allergy and Respiratory medicine (Hospital-based cancer registry division)
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-Ku, Okayama city, Okayama, 7008558, Japan
TEL
086-235-7227
Homepage URL
rai@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama 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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
| 2021 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.okayama-u.ac.jp/user/hospital/index16.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.okayama-u.ac.jp/user/hospital/index16.html
Number of participants that the trial has enrolled
38
Results
no problem in safety, however, significant relationship of device and real data could not observed.
Results date posted
| 2024 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients in hospital
Participant flow
normal inclusion
Adverse events
No adverse event
Outcome measures
No problem in safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 06 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049225
