UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042534 |
|---|---|
| Receipt number | R000048552 |
| Scientific Title | Effects of body pillows on sleeping position changes and sleep architecture |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2024/07/28 10:47:15 |
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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
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
park.insung.ge@u.tsukuba.ac.jp
Sponsor or person
Institute
IIIS, Human Physiology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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
| 2024 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048552
