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 UMIN000019762
Receipt No. R000022821
Scientific Title The single group study on how to take the rest using a phase mask for night shift workers
Date of disclosure of the study information 2015/12/01
Last modified on 2015/12/10

* 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 The single group study on how to take the rest using a phase mask for night shift workers
Acronym The single group study on how to take the rest using a phase mask for night shift workers
Scientific Title The single group study on how to take the rest using a phase mask for night shift workers
Scientific Title:Acronym The single group study on how to take the rest using a phase mask for night shift workers
Region
Japan

Condition
Condition Healthy people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 One of the effective methods in the rest nap during the night shift, and by using a phase mask to reveal that is effective in reduce fatigue take high quality nap.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Falling asleep feeling questionnaire, OSA sleep feeling questionnaire MA version
Key secondary outcomes BIS monitor

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 Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 The subjects get to participate for a total of two times during the night shift.The first time nap as usual, the second time to take a nap by using the eye mask.The plan to make that twice during the one month as the period.
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 Nurse of the relevant ward
Night shift (at 15:30 for the next day 9:00) nurses who are engaged in work
Age more than 20 years of age
Gender unquestioned
After receiving a sufficient explanation Upon participation in this study, on the thorough understanding, those who sentence consent voluntary participant himself was obtained
Key exclusion criteria Who there is an abnormality in the range that touches the eye mask, such as scratch swelling, eczema around the certain person or eyes and eye diseases and inflammation in the eye
Any person who is abnormalities such as scratches and swelling, eczema in part to affix the BIS of electrode
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sawa Tanaka
Organization Yamaguchi University Hospital
Division name Nursing department Spirit neurology ward
Zip code
Address Ube City, Yamaguchi Prefecture Minamikogushi 1-1-1
TEL 0836-22-2111
Email sawa.t@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sawa Tanaka
Organization Yamaguchi University Hospital
Division name Nursing department Spirit neurology ward
Zip code
Address Ube City, Yamaguchi Prefecture Minamikogushi 1-1-1
TEL 0836-22-2111
Homepage URL
Email sawa.t@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital Nursing department Spirit neurology ward
Institute
Department

Funding Source
Organization Yamaguchi University Hospital Nursing department
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
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 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 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
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 12 Day
Last modified on
2015 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.