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 UMIN000028270
Receipt No. R000032360
Scientific Title Development and effectiveness verification of sleep support system using sleeping sound in workplace
Date of disclosure of the study information 2017/07/20
Last modified on 2018/01/18

* 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 Development and effectiveness verification of sleep support system using sleeping sound in workplace
Acronym Development and effectiveness verification of sleep support system using sleeping sound in workplace
Scientific Title Development and effectiveness verification of sleep support system using sleeping sound in workplace
Scientific Title:Acronym Development and effectiveness verification of sleep support system using sleeping sound in workplace
Region
Japan

Condition
Condition healthy person
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aim to develop a sleep support system using sleeping sounds in the workplace, to improve the sleep quality of workers and to verify the effects on physical and mental health.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sleep duration, sleep efficiency, sleep latency after using sleep sound
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Each person sleeps in two patterns of sleeping sound and silence
Interventions/Control_2 Sleeping sound: 1 week (weekdays only)
Silence: 1 week (weekdays only)
TOTAL 2 weeks




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
65 years-old >=
Gender Male and Female
Key inclusion criteria Those who have insomnia tendency according to the Athens insomnia scale and who agreed to cooperate in study
Key exclusion criteria good sleeper
the deaf and hard of hearing
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari NAKADA
Organization Kanazawa Medical University
Division name Department of Nursing
Zip code
Address 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, Japan
TEL 076-286-2211
Email ynakada@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukari NAKADA
Organization Kanazawa Medical University
Division name Department of Nursing
Zip code
Address 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, Japan
TEL 076-286-2211
Homepage URL
Email ynakada@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Science and Technology Promotion Organization
Organization
Division
Category of Funding Organization Government offices of other countries
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 07 Month 20 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 12 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 31 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
2017 Year 07 Month 18 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032360

Research Plan
Registered date File name
2018/01/18 研究実施計画書(2017_快眠音)12.08.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.