UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033976
Receipt number R000038297
Scientific Title The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability
Date of disclosure of the study information 2018/09/01
Last modified on 2019/03/05 09:14:13

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Basic information

Public title

The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability

Acronym

The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability

Scientific Title

The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability

Scientific Title:Acronym

The development of sleeping support system in order to improve the sleep conditions based on relationship between worker 's stress and sleeplessness for the improvement of a self-care ability

Region

Japan


Condition

Condition

Sleeplessness

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The research aim is to monitor and follow up the daily amount of activity and sleep conditions, in order to improve a self-care capacity by using an activity level surveying instrument.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The score of the Athens insomnia measure after three months.

Key secondary outcomes

The Brief Job Stress Questionnaire


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

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

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

After wearing the activity meter for 2 weeks, we provide guidance on sleep hygiene by individual consultation and wear activity meter for 2 more weeks

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

22 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

Those interested in sleeping

Key exclusion criteria

Those diagnosed with insomnia

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiko Watanabe

Organization

NIIGATA SEIRYO UNIVERSITY

Division name

Department of nursing

Zip code


Address

1-5939, Suidocho, Chuo-ku, Niigata

TEL

0252669538

Email

miwatanabe@n-seiryo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Michiko Watanabe

Organization

Niigata seiryo university

Division name

Department of nursing

Zip code


Address

1-5939 suidoucho chuo-ku niigata

TEL

0252669538

Homepage URL


Email

miwatanabe@n-seiryo.ac.jp


Sponsor or person

Institute

Niigata seiryo university

Institute

Department

Personal name



Funding Source

Organization

Niigata seiryo 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


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

2018 Year 09 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

Enrolling by invitation

Date of protocol fixation

2018 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2018 Year 08 Month 20 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2020 Year 01 Month 31 Day

Date trial data considered complete

2020 Year 02 Month 29 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 08 Month 31 Day

Last modified on

2019 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name