UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of sole skin stimulation with noninvasive microcones on sleep
Title of the study (Brief title)	Effects of sole skin stimulation with noninvasive microcones on sleep
Region	Japan

Condition
Condition	insomnia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigated the effects of sole skin stimulation with noninvasive microcones on insomnia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	OSA sleep inventory MA version
Key secondary outcomes	Japanese version of the Epworth Sleepiness Scale

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Noninvasive microcones
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	26 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Over 26 and under 22 years old. Score of 6 or higher on the PSQI. Not receiving psychoactive or sleeping drugs. No problem with communication or intelligence. Provided signed written informed consent.
Key exclusion criteria	Diagnosis of depression, anxiety, schizophrenia or other severe mental disorder. Diagnosis of other sleep disorder such as obstructive sleep apnea or restless legs syndrome. Receiving other insomnia treatment in the past month. Alcohol and/or other drug abuse or dependence.
Target sample size	20

Research contact person
Name of lead principal investigator	Tomoyuki Nabeta
Organization	Morinomiya University of Medical Sciences
Division name	Department of Acupuncutre, Faculty of Health Sciences
Address	1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka 559-8611, Japan
TEL	06-6616-6911
Email	nabeta@morinomiya-u.ac.jp

Public contact
Name of contact person	Takashi Otsuki
Organization	Morinomiya University of Medical Sciences
Division name	Department of Acupuncutre, Faculty of Health Sciences
Address	1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka 559-8611, Japan
TEL	06-4703-5893
Homepage URL
Email	ootsuki@morinomiya-u.ac.jp

Sponsor
Institute	Morinomiya University of Medical Sciences
Institute
Department

Funding Source
Organization	Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kansai University of Health Sciences
Name of secondary funｄer(s)	Kansai University of Health Sciences

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	森ノ宮医療大学（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 14 Day
Anticipated trial start date	2017 Year 07 Month 14 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 14 Day
Last modified on	2018 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032271