UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation test of effectiveness for sleep improvement by suction of hydrogen
Acronym	A confirmation test of effectiveness for sleep improvement by suction of hydrogen
Scientific Title	A confirmation test of effectiveness for sleep improvement by suction of hydrogen
Scientific Title:Acronym	A confirmation test of effectiveness for sleep improvement by suction of hydrogen
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm effectiveness for sleep improvement by suction of hydrogen.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	* OSA sleep inventory * Pittsburgh Sleep Quality Index (Japanese edition)
Key secondary outcomes	* SCL30 * Multiple mood scale 40 questions * Activity level

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	First, using term of test equipment: Five minutes hydrogen suctioning, five times a day, consecutive for seven days. Coming clinic for test. Then, not using term of test equipment: For consecutive seven days. Coming clinic for test.
Interventions/Control_2	First, not using term of test equipment: For consecutive seven days. Coming clinic for test. Then, using term of test equipment: Five minutes hydrogen suctioning, five times a day, consecutive for seven days. Coming clinic for test.
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	30 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	(1) Females aged 30 to 45 years old who can't sleep well physiologically. (For examples, female who can't fall in sleep within 30 min, female who have middle awakening and/or female who are short of sleeping time) (2) Females who work over 4 days, 3.5 hours a day. (3) Females who can quit using of smartphone, cell phone and/or PC from one hour before bedtime. (4) Females who can quit drinking alcohol and caffeine after 5 pm during the test. (5) Females who have no plan of going to travel and/or staying at outside of the home during the test. (6) Females who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1) Females who have smoking habit. (2) Females who are cold-sensitive constitution. (including females like that who feel cold on their hands and foots even in summer) (3) Females who are currently receiving medication due to treatment of disease. (4) Females who go to hospital and/or subject who receive medicine, for treatment of sleep disorder. (5) Females who use supplements and/or health foods suspected to have influence to sleep. (6) Females with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more. (7) Females who notice their menopausal symptom. (8) Females who are pregnant (including the possibility of pregnancy) or are lactating. (9) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood. (10) In the past month, subjects who have had custom of taking or applying medicine for the treatment of diseases. (11) Subjects who have environment for sleep with their children or family at bed time. (12) Others who have been determined ineligible by investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Toshiharu Middle name Last name Miyake
Organization	Aqua Bank Co. Ltd
Division name	General Affairs Department
Zip code	541-0059
Address	1-8-15 Bakuromachi Chuo-ku Osaka-shi, Osaka 541-0059, Japan
TEL	06-6265-1034
Email	info-w@aqua-bank.co.jp

Public contact
Name of contact person	1st name Yukari Middle name Last name Hayashi
Organization	Aqua Bank Co. Ltd
Division name	General Affairs Department
Zip code	541-0059
Address	1-8-15 Bakuromachi Chuo-ku Osaka-shi, Osaka 541-0059, Japan
TEL	06-6265-1034
Homepage URL
Email	y-hayashi@aqua-bank.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Aqua Bank Co. Ltd
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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	2020 Year 10 Month 26 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	Completed
Date of protocol fixation	2019 Year 10 Month 21 Day
Date of IRB	2019 Year 10 Month 18 Day
Anticipated trial start date	2019 Year 10 Month 27 Day
Last follow-up date	2019 Year 11 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 26 Day
Last modified on	2020 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043750