UMIN-CTR Clinical Trial

Basic information
Public title	A verification test of the sleep improving effect of test equipment use
Acronym	A verification test of the sleep improving effect of test equipment use
Scientific Title	A verification test of the sleep improving effect of test equipment use
Scientific Title:Acronym	A verification test of the sleep improving effect of test equipment use
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify sleep improving effect of test equipment especially when using stretch function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*The sleep score (evaluated by single-channel EEG) *OSA questionnaire *Japanese version of the Epworth Sleepiness Scale
Key secondary outcomes	*The sleep diary *The incidence of side effects and/or adverse events.

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	Device,equipment
Interventions/Control_1	Sleeping with the functions of test equipment on every day, for a week. Resting for one week. Sleeping without the functions of the test equipment on every day, for a week.
Interventions/Control_2	Sleeping without the functions of test equipment on every day, for a week. Resting for one week. Sleeping with the functions of the test equipment on every day, for a week.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Male and female aged 30 to 64 when consent acquisition. 2) Subjects who have their body length 150cm to 185cm. 3) Subjects who answered that they don't satisfy their sleeping in questionnaire at preliminary test. 4) Subjects who are able to change their bedding to certain air-stretch mattress. 5) Subjects who are able to store their usual bedding during test period 6) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Key exclusion criteria	1) Subjects who have previous and/or current medical history of sleep impairment, or subjects who are being treated because of sleep impairment now. 2) Subjects who have been diagnosed as sleep apnea syndrome, or subjects who have noticed as apnea by themselves. 3) Subjects who have diagnosed as chronic low back pain, cervical spondylosis and/or osteoporosis in past, those disease are concerned about influence to using test device including stretch function. Or subjects who are being treated for the disease above. 4) Subjects who know that they easily to be influenced their sleep by environment change, such as using other bedding. 5) Subjects who don't be able to use sleep scope (single-channel EEG) during test period. 6) Subjects who have a planning of business trip or travel with lodging even once. 7) Subjects who don't be able to quit drink alcohol during test period. 8) Subjects who excessive alcohol intake. 9) Subjects who regularly use medicines, functional foods, foods for specified health use and/or supplements those concerned about influence for sleep. 10) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 12) Subjects who have severe menstrual pain or are diagnosed premenstrual syndrome (PMS). 13) Subjects who get a skin rash by attaching adhesive tape, because sensitive skin. 14) Subjects who use pacemaker. 15) Subjects who easily to get motion sickness. 16) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 17) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	0352973112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	0352973112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	MTG 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 Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel	0352975548
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 03 Month 19 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	20
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	2018 Year 09 Month 25 Day
Date of IRB	2018 Year 09 Month 06 Day
Anticipated trial start date	2019 Year 03 Month 19 Day
Last follow-up date	2020 Year 01 Month 31 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 03 Month 10 Day
Last modified on	2020 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041181