UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062565 |
|---|---|
| Receipt number | R000071608 |
| Scientific Title | Randomized Crossover Trial on the Effects of Differences in Housing Insulation Performance Grades on Sleep Architecture and Core Body Temperature in Healthy Adult Men |
| Date of disclosure of the study information | 2026/08/13 |
| Last modified on | 2026/08/12 20:08:23 |
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Basic information
Public title
The study on how differences in housing insulation performance affect sleep quality
Acronym
The study on Housing Insulation Performance and Sleep
Scientific Title
Randomized Crossover Trial on the Effects of Differences in Housing Insulation Performance Grades on Sleep Architecture and Core Body Temperature in Healthy Adult Men
Scientific Title:Acronym
House Insulation Sleep Trial
Region
| Japan |
Condition
Condition
Sleel
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantitatively clarify the impact of housing insulation performance on sleep architecture.
Basic objectives2
Others
Basic objectives -Others
This study is a randomized crossover trial involving healthy adult males aged 20 to 39, designed to examine the effects of bedroom environments with thermal insulation performance Grade 7 (high insulation) and Grade 4 (standard insulation) on sleep quality and quantity. The study aims to quantitatively elucidate the impact of Housing thermal insulation performance on sleep physiology by combining objective assessment via sleep EEG, core body temperature measurement using body surface sensors, and subjective assessment via questionnaires.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
N3 sleep (slow-wave sleep) Ratio
Key secondary outcomes
Sleep efficiency, arousal index, amount of REM sleep, core body temperature index, and subjective sleep quality.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention 1 (High-insulation condition): Overnight stay in a trailer house bedroom with Thermal Insulation Performance Grade 7
Interventions/Control_2
Intervention 2 (Standard insulation conditions): Overnight stay in a trailer house bedroom with Insulation Performance Grade 4.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Males aged 20 to 39 at the time of registration
Healthy adults (confirmed via medical questionnaire and physical assessment)
Individuals who have received an explanation regarding the study's purpose, methods, and risks, and who have provided voluntary written consent
Individuals capable of keeping a sleep diary and wearing an activity monitor for one week prior to the start of the experiment, and who can adhere to designated bedtimes and wake-up times (within+/-30 minutes)
Individuals capable of staying overnight at the research facility for three consecutive nights
Individuals capable of understanding explanations and completing questionnaires in Japanese
Key exclusion criteria
Individuals showing a 3% ODI more than 5 events/hour or a minimum SpO2<90% on overnight pulse oximetry
Individuals with an ESS score of 11 or higher
Individuals suspected of having insomnia, circadian rhythm sleep-wake disorders, sleep-related movement disorders, etc., based on medical history
Regular users of medications affecting sleep, such as hypnotics or psychotropic drugs
Individuals currently undergoing treatment for psychiatric, neurological, or endocrine disorders, or those with severe cardiac or respiratory disease
Shift workers or individuals planning travel involving a time difference of 3 hours or more during the study period
Individuals with skin conditions or allergies at the sites where electrodes or sensors are to be attached
Individuals currently participating in other studies, or those otherwise deemed unsuitable by the principal investigator
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Center for Environmental Conservation and Research Safety
Zip code
980-8574
Address
Department of Occupational Health, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7874
hiromasa.ogawa.d2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Center for Environmental Conservation and Research Safety
Zip code
980-8574
Address
Department of Occupational Health, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi,
TEL
022-717-7874
Homepage URL
hiromasa.ogawa.d2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi, 980-8574 Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2026 | Year | 08 | Month | 13 | 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
| 2026 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071608
