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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013166
Receipt No. R000015352
Scientific Title A trial for improving effects of high-voltage electric potential on sleeplessness and low temperature
Date of disclosure of the study information 2014/02/14
Last modified on 2017/01/30

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Basic information
Public title A trial for improving effects of high-voltage electric potential on sleeplessness and low temperature
Acronym A trial for improving effects of high-voltage electric potential on sleeplessness and low temperature
Scientific Title A trial for improving effects of high-voltage electric potential on sleeplessness and low temperature
Scientific Title:Acronym A trial for improving effects of high-voltage electric potential on sleeplessness and low temperature
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the device generating high-voltage electric potential improves sleeplessness and low body temperature in human.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sleep characteristics measured by SleepScan SL503
+ Sleep Score
+ Ratio of deep sleep
+ Number of nocturnal awakening
+ Ratio of nocturnal awakening
Key secondary outcomes Subjective symptoms
+ OSA sleep inventory MA version
+ Likert scales

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
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 Duration: 4 weeks
Test product: SunMedion 30000MaxH, the generator of high-voltage electric potential
Interventions/Control_2 Duration: 4 weeks
no treatments
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a) Males or postmenopausal women who are distressed by sleeplessness
b) Persons who has chairs made of other than metal, or who can set the specific chairs which will be lent by provider of the test material
Key exclusion criteria a) Persons who have previous medical history of heart failure or myocardial infarction
b) Patients being treated for at least one of following diseases; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease
c) Persons who take medicines, herbal medicines, or other therapeutic devices to treat severe pollinosis or by other reasons
d) Persons who are applied medical electronic equipment (self-contained device such as pacemakers, life-supporting equipment such as cardiopulmonary bypass, wearable devices such as electrocardiograph)
e) Persons who live with infants less than 1 years old
f) Persons whose sleep period or sleeping habits are irregular due to night works or other reasons
g) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
h) Persons who are judged not suitable to participate in this trial by physician.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Sanwa Co,. ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1303-1302-SC01-01-TC
Org. issuing International ID_1 Ethics Committee of Seishin-kai Medical Association Inc, Takara Medical Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Shinji T, Yamashita S, Suzuki N, Takara T : Effects of SunMedion 30000MaxH on sleep characteristics in people with sleeplessness. Journal of The Society for Integrative Medicine Japan (IMJ) 2014 ; 7(1) : 105-113.
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 Completed
Date of protocol fixation
2013 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 26 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015352

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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