UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061334 |
|---|---|
| Receipt number | R000070170 |
| Scientific Title | An Exploratory Non-randomized Crossover Study of Sleep Outcomes in Houses with Different Insulation Specifications (Winter) |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 14:27:49 |
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Basic information
Public title
An Exploratory Study of the Effects of Different Residential Insulation Specifications on Sleep (Winter)
Acronym
An Exploratory Study on Housing Insulation Specifications and Sleep (Winter)
Scientific Title
An Exploratory Non-randomized Crossover Study of Sleep Outcomes in Houses with Different Insulation Specifications (Winter)
Scientific Title:Acronym
A Comparative Study of Sleep Metrics in Homes with Different Insulation Specifications (Winter)
Region
| Japan |
Condition
Condition
Healthy adults with subjective sleep dissatisfaction
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the effects of differences in residential insulation methods on sleep in healthy Japanese adult men and women aged 20 years or older and younger than 70 years who are dissatisfied with their sleep in daily life, using sleep measurement with an EEG device, monitoring of sympathetic nervous activity with a pulse wave device, blood pressure measurement, and subjective sleep assessment with sleep questionnaires.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average values for each of the two nights of measurement in the two housing conditions with different thermal insulation specifications will be calculated for the sleep quality parameters derived from each participant's sleep data (total sleep time, sleep efficiency, sleep latency, time spent awake during the night, total duration and percentage of deep sleep, etc.), and the differences between them will be evaluated.
Key secondary outcomes
Subjective sleep-related indices assessed using the OSA Sleep Inventory MA version will be compared between two residential conditions with different insulation specifications.
Autonomic nervous system-related indices derived from heart rate variability during sleep will be exploratorily compared and analyzed between two residential conditions with different insulation specifications.
Blood pressure measured after waking will be exploratorily compared between two residential conditions with different insulation specifications.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will stay under Housing Condition 1 with a different insulation specification and undergo sleep measurement using an EEG device from bedtime until waking. In addition, sympathetic nervous activity will be monitored using a pulse wave device, blood pressure will be measured, and subjective sleep will be evaluated using sleep questionnaires.
Interventions/Control_2
Participants will stay under Housing Condition 2 with a different insulation specification and undergo sleep measurement using an EEG device from bedtime until waking. In addition, sympathetic nervous activity will be monitored using a pulse wave device, blood pressure will be measured, and subjective sleep will be evaluated using sleep questionnaires.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese adult men and women aged 20 years to less than 70 years who are dissatisfied with their sleep, are engaged in full-time work including housework and childcare, are able to provide voluntary informed consent, have a habitual time in bed of more than 5 hours based on their usual self-reported bedtime and wake-up time, and are able to stay at the designated study venue for a specified period.
Key exclusion criteria
Individuals currently receiving treatment for any disease, including medication, except those with mild chronic conditions such as hypertension, diabetes, hyperlipidemia, gout, or asthma whose symptoms are stable with medication and do not interfere with work. Individuals diagnosed with sleep disorders such as insomnia or sleep apnea who are taking sleep-inducing or insomnia medications, including over-the-counter drugs, or are being treated with CPAP or oral appliances. Individuals unable to restrict intake during the study period of foods for specified health uses, foods with functional claims, supplements, or health foods that may affect the study. Individuals suspected of having severe chronic or acute infectious disease. Individuals planning vaccination during the study period. Night-shift workers or rotating-shift workers. Individuals unable to avoid alcohol consumption and caffeine-containing beverages after 6 p.m. on EEG measurement days. Individuals whose habitual time in bed is less than 5 hours. Individuals with extremely irregular dietary habits. Individuals with a BMI of 30 or higher. Individuals currently participating in another clinical study of drugs or health foods, within one month after completion of such a study, or planning to participate in another clinical study after consenting to this study. Individuals unable to stay at the designated study venue for a specified period. Any other individuals judged by the principal investigator to be inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yoshimura |
Organization
Kobayashi Jutaku Co., Ltd.
Division name
Representative Director
Zip code
541-0047
Address
Yodoyabashi PREX 6F, 2-4-9 Hirano-machi, Chuo-ku, Osaka-shi, Osaka 541-0047, Japan
TEL
06-6766-4830
t-yoshimura@dreamhome.co.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Nakamura |
Organization
S'UIMIN Inc.
Division name
Business Division
Zip code
151-0061
Address
817 Hatsudai Center Building, 1-51-1 Hatsudai, Shibuya-ku, Tokyo 151-0061, Japan
TEL
03-6276-3662
Homepage URL
biz-cro@suimin.co.jp
Sponsor or person
Institute
S'UIMIN Inc.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Jutaku Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOKEN Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Institutions Sapporo Yuurinokai Hospital Clinical Trials Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.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
| 2026 | Year | 04 | Month | 21 | 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
20
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
| 2025 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 04 | 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
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070170
