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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009874
Receipt No. 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

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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
Institute Japan health and research institute
Institute
Department

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
URL(English) https://upload.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


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