UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of the shiki futon mattress on improving sleep quality
Acronym	A study to evaluate the effects of the shiki futon mattress on improving sleep quality
Scientific Title	A study to evaluate the effects of the shiki futon mattress on improving sleep quality
Scientific Title:Acronym	A study to evaluate the effects of the shiki futon mattress on improving sleep quality
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of the shiki futon mattress on improving sleep quality
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	OSA sleep inventory MA version
Key secondary outcomes	The St. Mary's Hospital sleep questionnaire, VAS, POMS 2nd edition short version, Activity tracker (SAT-1), Autonomic nervous function evaluation (spectral analysis of heart beat using myBeat and a-a interval of accelerated plethysmography)

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 on the novel type shiki futon -> Sleep on the conventional type shiki futon
Interventions/Control_2	Sleep on the conventional type shiki futon -> Sleep on the novel type shiki futon
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy males and females whose age of 20 years or more and less than 65 years 2. Subjects who are aware of impaired sleep quality 3. Subjects whose Pittsburgh Sleep Quality Index scores are 6 points or more 4. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Key exclusion criteria	1. Subjects receiving a medical treatment for sleep disorders 2. Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3. Subjects who take pharmaceuticals or quasi-drugs which having the efficacy for improving sleep quality 4. Subjects who take Foods with Function Claims labeled the effect of improving sleep quality 5. Subjects whose lifestyles are irregular because of night shift or others 6. Subjects who wake up for urination 2 times or more during nocturnal sleep 7. Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 8. Subjects who take part in another clinical study 9. Female subjects who are pregnant or lactating, or intending to become pregnant during the study 10. Subjects deemed unsuitable by the investigator
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Yamakura
Organization	SHOWA NISHIKAWA CO., LTD.
Division name	Director
Zip code	103-0007
Address	1-4-15, Nihonbashi-Hamacho, Chuo-ku, Tokyo
TEL	03-5687-2724
Email	yamakura@showanishikawa.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Sugino
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	SHOWA NISHIKAWA 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	IRB of Fukuda Clinic
Address	Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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	2022 Year 03 Month 31 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	18
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	2020 Year 12 Month 19 Day
Date of IRB	2020 Year 12 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 27 Day
Last follow-up date	2021 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 05 Month 30 Day
Date analysis concluded	2021 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 02 Month 03 Day
Last modified on	2022 Year 02 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053413