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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042534 |
Receipt No. | 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 | 2020/11/24 |
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 |
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Condition | ||
Condition | Nothing | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |