UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009874
Receipt number R000011545
Scientific Title Inetrventional study of to assess the effectiveness of airweave to sleep quality
Date of disclosure of the study information 2013/01/25
Last modified on 2013/01/25 18:56:38

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Basic information

Public title

Inetrventional study of to assess the effectiveness of airweave to sleep quality

Acronym

Airweave Test

Scientific Title

Inetrventional study of to assess the effectiveness of airweave to sleep quality

Scientific Title:Acronym

Airweave Test

Region

Japan


Condition

Condition

Sleep disorder, Shoulder pain, Hip pain, Stress

Classification by specialty

Medicine in general Psychiatry Orthopedics
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effectiveness of airweave to sleep quality and health condition

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

EEG

Key secondary outcomes

POMS, Subjective health status


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Sleep with airweave concecutive 7days

Interventions/Control_2

Sleep with ordinary bed or futon concecutive 7 days

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Hot spring trainer who can bathe in Onsen everyday

Key exclusion criteria

Who can not bath in hot water everyday

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuak

Organization

Japan health and research institute

Division name

Onsen medical science research center

Zip code


Address

1-29-4 Nihonbashikakikaracho Chuo-ku Tokyo

TEL

+81-3-3668-1261

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuaki Goto

Organization

Japan health and research institute

Division name

Onsen medical science research center

Zip code


Address


TEL


Homepage URL


Email

ygoto@jph-ri.or.jp


Sponsor or person

Institute

Japan health and research institute

Institute

Department

Personal name



Funding Source

Organization

Airweave Cooreratiion

Organization

Division

Category of Funding Organization

Profit organization

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

2013 Year 01 Month 25 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

No longer recruiting

Date of protocol fixation

2012 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 23 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

2013 Year 01 Month 25 Day

Last modified on

2013 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011545


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name