UMIN-CTR Clinical Trial

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
Email	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
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	Shiga University of Medical Science
Address	Seta Tsukinowa-cho, Otsu, Shiga
Tel	077-548-3576
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037115