UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A trial for improving effects of high-voltage electric potential on sleeplessness and low temperature
Title of the study (Brief title)	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
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether "Cosmo. Dr 14000" 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 OSA sleep inventory MA version sleepiness on rising initiation and maintenance of sleep frequent dreaming refreshing sleep length
Key secondary outcomes	Likert scales body temperature measurement

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: Cosmo. Dr 14000
Interventions/Control_2	Duration: 4 weeks Test product:none
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	40 years-old <=
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 are over 40 years old
Key exclusion criteria	a) Persons who have previous medical history of malignant tumor or 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 6 years old f) Persons whose sleep period or sleeping habits are irregular due to night works or other reasons g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons whose menstruation cycle is irregular i) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial j) Persons who are judged not suitable to participate in this trial by physician.
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
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	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
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	Health Net 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)

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	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 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 14 Day
Anticipated trial start date	2014 Year 05 Month 14 Day
Last follow-up date	2014 Year 09 Month 01 Day
Date of closure to data entry	2014 Year 09 Month 01 Day
Date trial data considered complete	2014 Year 09 Month 01 Day
Date analysis concluded	2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 06 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=R000016530