UMIN-CTR Clinical Trial

Basic information
Public title	Effects of body pillows on sleeping position changes and sleep architecture
Acronym	Effects of body pillows on sleeping position changes and sleep architecture
Scientific Title	Effects of body pillows on sleeping position changes and sleep architecture
Scientific Title:Acronym	Effects of body pillows on sleeping position changes and sleep architecture
Region	Japan

Condition
Condition	Nothing
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we used a body pillow specialized for supporting lateral sleeping position for subjects with high consumer needs, so that sleep time, breathing, and sleep time for each position during sleep. Compare and determine the effects on sleep architecture.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Sleep duration for each position 2. Occurrence rate of each sleep stage by polysomnography recording 3. Energy metabolism index
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Body pillow
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy middle-aged male and female
Key exclusion criteria	1 Those with a systolic blood pressure of 90 mmHg or less 2 Those who are participating in other exams as test subjects or who have participated within 4 weeks after the end of the test 3 Those who fall under any of the following items a. diseases of the heart, liver, kidneys, stomach_excessive gastric acid, gastric ulcer_including complications of other diseases b. a history of cardiovascular disease c. Those who have diabetes d. Those who are allergic to test bedding 4 Those with claustrophobia 5 judged by the investigator to be inappropriate for the examination 6 Those who regularly use pharmaceuticals, foods for specified health use, foods with functional claims, health foods, etc. 7 Persons with a history of significant liver dysfunction, renal dysfunction, or cardiovascular disease 8 under 30 years old 9 Those who have been treated for mental illness or sleep disorders, those who have symptoms that are currently being treated 10 Those who live irregularly_regular life_ go to bed from 2100 to 0100, wake up from 0600 to 0900, sleep time for 7 to 9 hours 11 Those who are lean_BMI less than 18.5_or obese_BMI 25 or more 12 Persons who have been engaged in night shift_after 2200_within the past 3 months 13 Those who have traveled to a country with a time difference of 3 hours or more within the past 3 months 14 Those who drink habitually_40 g of pure alcohol_approximate 2 cans of beer_ or more drink at least twice a week 15 Those who have a smoking habit 16 Those who have a daily intake of the caffeine of 300 mg_approximate 5 cups of 150 mL coffee or more
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Insung Middle name Last name Park
Organization	Univ. Tsukuba
Division name	IIIS
Zip code	3058550
Address	Tennnodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	0298591858
Email	park.insung.ge@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name INSUNG Middle name Last name PARK
Organization	University of Tsukuba
Division name	IIIS
Zip code	305-8550
Address	Tennnodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	0298591858
Homepage URL
Email	park.insung.ge@u.tsukuba.ac.jp

Sponsor
Institute	IIIS, Human Physiology
Institute
Department

Funding Source
Organization	Tokyo Nishikawa
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	IIIS
Address	Tennnodai 1-1-1, Tsukuba, Ibaraki, Japan
Tel	0298591858
Email	park.insung.ge@u.tsukub.ac.jp

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	2020 Year 11 Month 30 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	2020 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 31 Day
Last follow-up date	2022 Year 03 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	2020 Year 11 Month 24 Day
Last modified on	2021 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048552

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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