UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052440 |
|---|---|
| Receipt number | R000059855 |
| Scientific Title | Effects of airflow into the bedding on circadian rhythm and quality of sleep |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2023/10/08 11:14:11 |
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Basic information
Public title
Effects of airflow into the bedding on circadian rhythm and quality of sleep
Acronym
Effects of airflow into the bedding on circadian rhythm and quality of sleep
Scientific Title
Effects of airflow into the bedding on circadian rhythm and quality of sleep
Scientific Title:Acronym
Effects of airflow into the bedding on circadian rhythm and quality of sleep
Region
| Japan |
Condition
Condition
Normal subjects
20 male and 20 female subjects between the ages of 18 and 35 (10 for the summer experiment and 10 for the winter experiment).
Females will be asked to participate after menstruation ends.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine the effect of airflow into the sleeping area on lowering deep body temperature in summer and winter. The hypotheses for the specific objectives of the study are described below.Hypothesis:It is possible to lower deep body temperature by changing the temperature and humidity in the bed in summer and winter, respectively.Action in summer;The temperature in the bed is kept at a comfortable level (28 degrees Celsius) during sleep, and the humidity is lowered by generating air currents, thereby lowering the deep body temperature during sleep.In winter, it lowers humidity and deep body temperature during sleep by making the inside of the bed a comfortable temperature (28 degrees Celsius) and generating air currents.The temperature and humidity settings of the air blower shall be as follows.Physiological experiments conducted under the condition of sleeping only with clothes on showed that the quality of sleep decreased with a mild decrease in room temperature (24 degrees Celsius) and an increase in room temperature (37 degrees Celsius) compared to a room temperature of 29 degrees Celsius. In addition, other literature indicates that a comfortable room temperature for sleep is 25-28 degrees Celsius. In other literature, a comfortable room temperature for sleep is 25-28 degrees Celsius. Therefore, the comfortable temperature in the bed was set to 25-28 degrees Celsius, and experiments were conducted in both summer and winter so that the temperature in the bed would be within this range. In summer, the room temperature is set to a comfortable temperature and air is blown into the bed to keep the temperature inside the bed at a comfortable level even when a human body is inside the bed. On the other hand, in winter, the room temperature tends to be low even if an air conditioner is used, and the subject's body is too cold to provide a heat source of about 37 degrees Celsius, so the temperature in the bed tends to drop.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A total of three sleep experiments will be conducted per subject using fire-retardant bedding and a fire-retardant comforter (summer comforter in summer and winter comforter in winter) for three nights:the first night without air circulation (first night effect, condition for acclimation to measuring equipment, etc.;experimental data will not be used), the second night without air circulation, and the third night with air circulation. In the condition without air blowing (standard condition), it is not necessary to make a quilt dome inside the bed by air blowing, and the subject can choose a towelette according to his/her preference. The conditions without and with air blowing will be conducted randomly by the subjects in order to consider the sequential effect. Sleep experiments will be conducted three times with at least one night between conditions, because the effect of the airflow may appear on the next night if the sleep experiments are conducted on consecutive nights. Sleepwear will be provided and socks will not be worn.
All subjects will be set at 25-28 degrees Celsius in the summer and 25-28 degrees Celsius in the winter. However, if the room temperature is colder than 25 degrees Celsius during the nighttime in the summer air blowing experiment, both cooling and heating will be used.Assessment items include polysomnogram, body movement, skin temperature, subjective survey, and other items related to sleep and its recovery, as well as measurement of environmental temperature.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blowing power condition (summer and winter): 3 hours a day at 30-50% of maximum output (air volume 0.9 m^3/min, air speed 1.2 m/sec x 4 fans) from bedtime
One day under control conditions (no airflow)
One day for the first night effect (no airflow)
Total 3 days of experiment.
Rationale for air volume: The airflow is designed to be strong enough so that air blown to the feet in the bed does not blow away from the head.
Rationale for the airflow duration: The airflow is set to stop when the lowest point of the circadian rhythm is reached after the sleep cycle of approximately 90 minutes is repeated twice.
Air temperature condition: The target temperature is set to 28-31 degrees Celsius in both summer and winter as a temperature that is lower than the deep body temperature and promotes perspiration, referring to the comfortable temperature in the beds in previous studies.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult men and women with normal circadian rhythms will be included. The following exclusion criteria were also established.
Key exclusion criteria
Exclusion Criteria:
No physician-diagnosed sleep disorder and healthy both physically and mentally.
-No diagnosis of coldness or circulatory system disease.
-The patient must not have a sensitive skin or be allergic to alcohol, as the application of the electrodes may cause skin irritation.
Not be able to make a decision on whether or not to participate in the study by themselves.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | shima |
| Middle name | |
| Last name | okada |
Organization
Ritsumeikan University
Division name
Science & Engineering
Zip code
5258577
Address
1-1-1, Nojihigashi, Kusatsu, Shiga, Japan
TEL
0775614939
s-okada@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | shima |
| Middle name | |
| Last name | okada |
Organization
Ritsumeikan University
Division name
Science & Engineering
Zip code
5258577
Address
1-1-1, Nojihigashi, Kusatsu, Shiga, Japan
TEL
0775614939
Homepage URL
s-okada@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University Ethics Review Committee for Medical Research Involving Human Subjects
Address
1-1-1, Nojihigashi, Kusatsu, Shiga, Japan
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2023 | Year | 10 | Month | 15 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 08 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059855
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