UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040795 |
|---|---|
| Receipt number | R000046582 |
| Scientific Title | A prospective observational study of body temperature estimation and sleep quality from sensors attached to pillowcases at bedtime |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2022/06/20 04:43:20 |
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Basic information
Public title
A prospective observational study of body temperature estimation and sleep quality from sensors attached to pillowcases at bedtime
Acronym
Development of a Method for Estimating Body Temperature Using a Sensor Attached to a Pillowcase
Scientific Title
A prospective observational study of body temperature estimation and sleep quality from sensors attached to pillowcases at bedtime
Scientific Title:Acronym
A prospective observational study of body temperature estimation and sleep quality from sensors attached to pillowcases at bedtime
Region
| Japan |
Condition
Condition
General healthy people and patients with infectious diseases
Classification by specialty
| Infectious disease | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The body temperature at bedtime is the most stable since the influence of heat production by muscles is small. It's time to do it. Changes in body temperature are known to be altered by infection, poor health, female sexual cycles, etc. COVID- 19 and other new infections, symptoms of fever and coughing have been reported without the person's knowledge, and the infection To study the possibility of infection and to monitor asymptomatic patients with confirmed infections when they are treated at home or in facilities. The purpose of this project is to develop it as a device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ear hole temperature, wristwatch activity meter, EEG, EKG, EKG, breathing belt, pillowcase with sensors (temperature and humidity, acceleration, microphone)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
General healthy people and patients with infectious diseases
Key exclusion criteria
Trauma, bleeding disorders, psychiatric disorders, dementia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University
Division name
Biomedical engineering
Zip code
9800845
Address
468-1 Resilient403 Aoba Aramaki Aoba-ku Sendai-shi Miyagi-ken JAPAN
TEL
022-752-2206
keizo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keizo |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University
Division name
Biomedical engineering
Zip code
9800845
Address
468-1 Resilient403 Aoba Aramaki Aoba-ku Sendai-shi Miyagi-ken JAPAN
TEL
022-752-2206
Homepage URL
keizo@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
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
Tohoku University
Address
468-1 Resilient403 Aoba Aramaki Aoba-ku Sendai-shi Miyagi-ken JAPAN
Tel
0227522206
keizo@med.tohoku.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
| 2020 | Year | 11 | 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
| 2020 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ear canal temperature, wristwatch activity meter, EEG, EKG, EKG, respiratory belt, pillowcase with sensors (temperature, humidity, acceleration, microphone) measured at bedtime for one week
Management information
Registered date
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046582
