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 2022/05/29 11:32:25

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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

Email

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


Email

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

Email

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


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

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



Other

Other related information



Management information

Registered date

2021 Year 01 Month 25 Day

Last modified on

2022 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049225


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name