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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035640
Receipt No. R000040599
Scientific Title Effects of mattresses and pillows on sleeping body posture and sleep architecture
Date of disclosure of the study information 2021/03/31
Last modified on 2019/01/23

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Basic information
Public title Effects of mattresses and pillows on sleeping body posture and sleep architecture
Acronym Effects of bedding change on sleeping posture and sleep architecture
Scientific Title Effects of mattresses and pillows on sleeping body posture and sleep architecture
Scientific Title:Acronym Effects of bedding change on sleeping posture and sleep architecture
Region
Japan

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

Objectives
Narrative objectives1 In this study, we compare the influence on breathing and sleep architecture for each posture during sleep by using mattress or pillow for healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sleep duration for each position during sleep.
Rate of each sleep stage by sleep polysomnography recording.
Energy metabolism.
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 No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Only control mattress.
Interventions/Control_2 Only &free mattress.
Interventions/Control_3 Control mattress and pillow.
Interventions/Control_4 &free mattress and pillow.
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
59 years-old >=
Gender Male and Female
Key inclusion criteria Healthy men and women without sleep problems.
Key exclusion criteria 1) Systolic blood pressure is 90 mmHg or less
2) Participants as a test in another test, or within 4 weeks after the examination
3) subject who falls under any of the following items
a) Person who has a disease in the heart, liver, kidney, stomach (stomach acid excess, gastric ulcer) (including cases of complications of other diseases)
b) Person who has a history of cardiovascular disease
c) Person who develops diabetes
d) Persons who are allergic to test bedding
4) A person with claustrophobia.
5) Person who judged that the examination responsible doctor is inappropriate for the examination
6) Persons who regularly use medicines, foods for specified health use, functional display foods, health foods etc.
7) Persons who have a remarkable history of liver dysfunction, renal dysfunction, cardiovascular disease
8) Aged 60 and over and under 20
9) Subject who have been treated for psychiatric disorders or sleep disorders so far, those who currently have symptoms to be treated
10) Persons who are living irregularly (Regular life: 21: 00 ~ 1: 00 bedtime, wake up from 6: 00 ~ 9: 00, sleeping time of 7 ~ 9 hours)
11) Persons who are of a body type of a lean type (BMI less than 18.5) or an obese type (BMI 25 or more)
12) Person engaged in night shift (after 22 o'clock) within the past 3 months
13) Person who has traveled to a country with a time difference of 3 hours or more within the past 3 months
14) Habitually drinking alcohol (pure alcohol 40 g [guideline: 2 cans of beer] more than twice a week or more
15) Those who have a smoking habit
16) Person who has more than 300 mg caffeine intake per day (standard: 150 cups of coffee)
17) Those who score 30 points or less (obvious night type) or 70 points (obvious morning) for the morning type / night type question paper
18) Persons who weigh 36.3 kg or less
19) Person who has abnormality in vomiting reflex
20) Persons who have embedded electronic equipment in the body such as pacemakers
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoh Makoto
Organization University of Tsukuba
Division name IIIS
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-5643
Email satoh.makoto.fu@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name INSUNG PARK
Organization University of Tsukuba
Division name IIIS
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-5643
Homepage URL
Email park.insung.ge@u.tsukuba.ac.jp

Sponsor
Institute International Institute for Integrative Sleep Medicine
Institute
Department

Funding Source
Organization NIshikawa Ins.
Organization
Division
Category of Funding Organization Non profit foundation
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
2021 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
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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