UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035640 |
|---|---|
| Receipt number | 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 | 2024/07/28 10:47:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Makoto |
| Middle name | |
| Last name | Satoh |
Organization
University of Tsukuba
Division name
IIIS
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-5643
satoh.makoto.fu@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
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-5643
Homepage URL
park.insung.ge@u.tsukuba.ac.jp
Sponsor or person
Institute
International Institute for Integrative Sleep Medicine
Institute
Department
Personal name
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
-
-
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
https://www.sleepmedres.org/journal/view.php?doi=10.17241/smr.2021.00878
Publication of results
Published
Result
URL related to results and publications
https://www.sleepmedres.org/journal/view.php?doi=10.17241/smr.2021.00878
Number of participants that the trial has enrolled
10
Results
Body pillow use, however, signifi- cantly extended the sustained time spent in the lateral body position compared with the control trial. Subjective sleep quality and sleep architecture did not differ significantly between the 2 trials, but body pillow use decreased the number of short (30 s) slow-wave sleep episodes.
Results date posted
| 2024 | Year | 07 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All participants, 10 healthy young adults (4 male, 6 female), satisfied the inclusion criteria: 20 to 65 years of age, BMI 18.5 to 25 (kg/ m2), a regular sleep/wake pattern, and not engaged in regular exercise more than twice a week. Exclusion criteria were as follows: self-reported sleep problems (Pittsburgh Sleep Quality Index score > 5); shiftwork or transmeridian travel within 3 months before the study; smoking; excessive alcohol intake (> 30 g/day); currently taking medication for cardiovascular disease, hyper- tension, diabetes, hypercholesterolemia, hyperglycemia, or hyperlipidemia; use of medications affecting sleep or metabolism; and severe sleep apnea syndrome. The Morningness-Eveningness Questionnaire (MEQ) was administered to eliminate participants having an extreme morning and evening type (41 < MEQ scores < 59).
Participant flow
In this experiment was a randomized-crossover intervention study with or without body pillow use, which were separated a wash- out period of more than 1 week. One week preceding the experiment, the participants stayed in a whole room metabolic chamber as an adaptation night, during which the sensors and electrodes of the polysomnographic (PSG) recording system were attached to the participants. Three days prior to the experiment, the participants were instructed to maintain a constant 8 h sleep/16 h wake schedule following their habitual bed and awake time and to refrain from taking naps, which was confirmed by wrist actigraphy (ActiGraph, Ambulatory Monitoring, NY, USA), and to complete daily diaries. Participants refrained from ingesting caffeine and alcohol for 1 week prior to the experiment.
Adverse events
None
Outcome measures
Subjectively / objectively sleep quality and body positions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
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
| 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=R000040599
