UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029234
Receipt No. R000032407
Scientific Title Validation analysis of performance of novel sleep sensing system
Date of disclosure of the study information 2017/10/01
Last modified on 2018/03/23

* 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 Validation analysis of performance of novel sleep sensing system
Acronym Evaluation of Smart Eye Mask
Scientific Title Validation analysis of performance of novel sleep sensing system
Scientific Title:Acronym Evaluation of Smart Eye Mask
Region
Japan

Condition
Condition sleep disorder
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison between Smart Eye Mask and PSG
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of sleep stage classification derived from Smart Eye Mask
Key secondary outcomes

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 Monitor the sleep by using Smart Eye Mask and PSG at a night
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteer
Key exclusion criteria Healthy volunteer without informed consent
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Nagano
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL 078-382-5660
Email tnagano@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Nagano
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL 078-382-5660
Homepage URL
Email tnagano@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University Graduate School of Engineering Faculty of Engineering
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 Year 03 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 01 Day
Date analysis concluded
2018 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 21 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.