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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032583
Receipt No. 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 2019/05/15

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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
Middle name
Last name Kenichi Kuriyama
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2291
Email kenichik@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Ichiba
Organization Kao Corporation
Division name Personal Health Care Research
Zip code
Address 2-1-3, Bunka Sumida-ku Tokyo 131-8501, Japan
TEL 0356307271
Homepage URL
Email ichiba.tomohisa@kao.com

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
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
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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