UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032583 |
|---|---|
| Receipt number | R000037115 |
| Scientific Title | The effect and mechanism of periocular skin warming stimulus on sleep |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2022/04/15 13:10:50 |
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Basic information
Public title
The effect and mechanism of periocular skin warming stimulus on sleep
Acronym
Effect of warming stimulus on sleep
Scientific Title
The effect and mechanism of periocular skin warming stimulus on sleep
Scientific Title:Acronym
Effect of warming stimulus on sleep
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of periocular warming at bedtime on sleep complaints and physiological condition during sleeping in middle-aged adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Pittsburgh Sleep Quality Index (PSQI) global score and component score of sleep latency
Key secondary outcomes
-Self-reported sleep status
-The changes of the EEG sleep variables (Sleep latency, Wake after sleep onset, Total sleep time, Sleep efficiency, each sleep stage, etc)
-The changes of the frequency calculated by EEG
-The changes of heart rate and heart rate variability by obtained ECG
-The changes of respiration rate
-The changes of body temperature
-The Activity-based sleep monitor
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult male and female with sleep difficulty
Key exclusion criteria
-Patient having psychiatric disorders other than sleep disorder
-Patient having sleep disorder other than insomnia disorders (hypersomnolence disorder, breathing- related sleep disorders, parasomnias. etc.)
-Patient having caused the body trouble by periocular warming in the past
-Patient having following diseases; cardiovascular disease, a neuropsychiatric disorder (alcohol/drug dependence or abuse, a suicide feeling, and the past attempted suicide history), an allergy disease, a kidney and urological diseases
-Patient having following lifestyle; habitual drinking, shift worker, traveling abroad
-The woman under pregnancy and breast-feeding, or the woman who may have become pregnant
-Taking part in and will be going to take part in the other clinical trials during the study period.
-Patients who are determined unsuitable by principal investigators
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2291
kenichik@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Ichiba |
Organization
Kao Corporation
Division name
Personal Health Care Research
Zip code
131-8501
Address
2-1-3, Bunka Sumida-ku Tokyo 131-8501, Japan
TEL
0356307271
Homepage URL
ichiba.tomohisa@kao.com
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2018 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pittsburgh Sleep Quality Index global score
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037115
