UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028233 |
|---|---|
| Receipt number | 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 14:13:13 |
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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
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
ootsuki@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032271
