UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the functional mattress on sleep
Acronym	The effect of the functional mattress on sleep
Scientific Title	The effect of the functional mattress on sleep
Scientific Title:Acronym	The effect of the functional mattress on sleep
Region	Japan

Condition
Condition	healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To exam the effect of the mattress on sleep
Basic objectives2	Others
Basic objectives -Others	sleep experiment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG during sleep
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Sleep in the functional mattress
Interventions/Control_2	Sleep in the usual mattress
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	29 years-old >
Gender	Male
Key inclusion criteria	No sleep problem
Key exclusion criteria	Smoker Shift worker
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Satoh
Organization	University of Tsukuba
Division name	International Institute for integrative sleep medicine
Zip code
Address	Tennodai 1-1-1, Tsukuba, Ibaraki
TEL	029-853-5643
Email	mk-satoh@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Satoh
Organization	University of Tsukuba
Division name	International Institute for integrative sleep medicine
Zip code
Address	Tennodai 1-1-1, Tsukuba, Ibaraki
TEL	029-853-5643
Homepage URL
Email	mk-satoh@md.tsukuba.ac.jp

Sponsor
Institute	International Institute for integrative sleep medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Nishikawa Sangyo 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
Address
Tel
Email

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	2017 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.17241/smr.2019.00423
Number of participants that the trial has enrolled	10
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	2016 Year 05 Month 29 Day
Date of IRB	2016 Year 05 Month 29 Day
Anticipated trial start date	2016 Year 05 Month 29 Day
Last follow-up date	2019 Year 12 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	2017 Year 02 Month 15 Day
Last modified on	2020 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030053