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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028233
Receipt No. R000032271
Scientific Title Effects of sole skin stimulation with noninvasive microcones on sleep
Date of disclosure of the study information 2017/07/14
Last modified on 2018/07/18

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Basic information
Public title Effects of sole skin stimulation with noninvasive microcones on sleep
Acronym Effects of sole skin stimulation with noninvasive microcones on sleep
Scientific Title Effects of sole skin stimulation with noninvasive microcones on sleep
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomoyuki Nabeta
Organization Morinomiya University of Medical Sciences
Division name Department of Acupuncutre, Faculty of Health Sciences
Zip code
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
1st name
Middle name
Last name Takashi Otsuki
Organization Morinomiya University of Medical Sciences
Division name Department of Acupuncutre, Faculty of Health Sciences
Zip code
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

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 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

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
2017 Year 07 Month 14 Day
Date of IRB
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

Other
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

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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