UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021007 |
|---|---|
| Receipt number | R000024245 |
| Scientific Title | Study on the effect of bedtime periocular warming on sleep |
| Date of disclosure of the study information | 2016/02/13 |
| Last modified on | 2016/03/04 12:46:08 |
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Basic information
Public title
Study on the effect of bedtime periocular warming on sleep
Acronym
Effects of periocular warming on sleep
Scientific Title
Study on the effect of bedtime periocular warming on sleep
Scientific Title:Acronym
Effects of periocular warming on sleep
Region
| Japan |
Condition
Condition
sleep difficulty
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of periocular warming for a week on subjective sleep states in a single blind manner
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective measures on sleep quality and quantity following to the periocular warming for a week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
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
Warming periocular region with a heat-generating sheet which warm the skin underneath it up to 40
degree Celsius and examining its effects on sleep
Interventions/Control_2
Using a sham sheet similar in appearance to the heat-generating sheet and examining its effects on sleep
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
Female
Key inclusion criteria
Adult women who have mild difficulty sleeping indicated by Pittsburgh sleep quality index score 5.5 or larger but suffer from no other serious clinical sleep disorders
Key exclusion criteria
History or comorbidity of major physical or mental disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Uchiyama |
Organization
Nihon University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
Oyaguchi-Kamicho, Itabashi, Tokyo
TEL
03-3972-8111
uchiyama.makoto@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Nakamoto |
Organization
Kao Corp.
Division name
Personal health care laboratory
Zip code
Address
Bunka 2-1-3 Sumida, Tokyo
TEL
03-5630-7271
Homepage URL
sakamoto.ichioro@kao.co.jp
Sponsor or person
Institute
Kai Corp.
Institute
Department
Personal name
Funding Source
Organization
Kai Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2016 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 13 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024245
