UMIN-CTR Clinical Trial

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
Email	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
Email	keizo@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046582