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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name