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 2022/11/28 14:52:51

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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

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 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

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

No longer recruiting

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

2022 Year 11 Month 28 Day



Link to view the page

Value
https://center6.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