UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047493 |
|---|---|
| Receipt number | R000054153 |
| 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 |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/09/08 11:41:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054153
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
