UMIN-CTR Clinical Trial

Basic information
Public title	Study to verify the effect of sleep quality improvement and QOL and menopausal symptoms change by using 4-layer special three-dimensional mattress
Acronym	Study to verify the effect of sleep quality improvement and QOL and menopausal symptoms change by using 4-layer special three-dimensional mattress
Scientific Title	Study to verify the effect of sleep quality improvement and QOL and menopausal symptoms change by using 4-layer special three-dimensional mattress
Scientific Title:Acronym	Study to verify the effect of sleep quality improvement and QOL and menopausal symptoms change by using 4-layer special three-dimensional mattress
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to examine the effects on sleep quality, quality of life and menopausal symptoms by using a 4-layer special three-dimensional mattress for 8 weeks in premenopausal women aged 45 to 54 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japanese version of the Pittsburgh Sleep Quality Index,OSA sleep inventory MA version,Anti-Aging QOL Common Questionnaire,SF-36v2,SMI
Key secondary outcomes	MDQ,E2,Progesterone,DHEA-S,LH,FSH

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Use 4-layer special three-dimensional mattress(8Weeks)
Interventions/Control_2
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	45 years-old <=
Age-upper limit	55 years-old >
Gender	Female
Key inclusion criteria	[1]Premenopausal female aged between 45 and 54 at the time of informed consent [2]Individuals who are healthy and have no chronic physical disease including skin disease. [3]Individuals who are aware of mild sleep disorders such as waking up in the middle of the night (midway awakening), waking up early in the morning (early morning awakening), and not feeling well asleep (deep sleep disorder) [4] Individuals who are aware of menopausal symptoms (irritability, anxiety, mood discomfort, insomnia, hot flashes, etc.) [5]Individuals who work 3 to 5 days a week during the day and are on weekends and public holidays [6]Individuals whose sleeping hours are over 4 hours from lights-out to rising and time of lights-out and rising is regular and bedtime is every 24th hours [7]Individuals who are sleeping alone [8]Individuals who do not have a habit of drinking alcohol [9]Individuals whose written informed consent has been obtained. [10]Individuals who can come to the designated venue for this study and be inspected. [11]Individuals judged appropriate for this study by responsible doctor
Key exclusion criteria	Individuals (who) [1] contract disease and are under treatment [2] under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3] have a history of and/or contract serious diseases (eg, Uterine disease,liver disease, kidney disease, heart disease, lung disease, blood disease) [4] have a history and/or contract digestive disease [5] receiving hormone replacement therapy [6] are suspected, recived treatment of, or have a history of sleep apnea syndrome [7] have or are suspected with the night urination or overactive bladder [8] receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [9] BMI are 30 or more [10] have a habit to use functional foods and/or are planning to use those foods during test periods [11] donated 200 mL of blood in the past month or more than 400 mL within 3 months [12] with possible changes of life style during test periods [13] are participating and/or had participated in other clinical studies within the last 3 months [14] are or are possibly pregnant, or are breastfeeding [15] are judged as not appropriate to this study by a responsible doctor
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Zip code	610-0392
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Toshiyasu Middle name Last name Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Zip code	110-0015
Address	6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL	03-6801-8400
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	Anti-Aging Bank Co.,Ltd.
Institute
Department

Funding Source
Organization	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	Society of Glycative Stress Research
Address	5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel	03-6709-8842
Email	rinri-glycativestress@antiaging-bank.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	うえのあさがおクリニック

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 20 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	12
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	2022 Year 03 Month 29 Day
Date of IRB	2022 Year 04 Month 15 Day
Anticipated trial start date	2022 Year 04 Month 21 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2022 Year 09 Month 07 Day
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2022 Year 04 Month 15 Day
Last modified on	2022 Year 09 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054153