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
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
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
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
