UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039577
Receipt number R000045136
Scientific Title Effect of auricular acupuncture on somnolence, depression, and learning context.
Date of disclosure of the study information 2020/09/01
Last modified on 2020/02/23 22:30:47

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Basic information

Public title

Effect of auricular acupuncture on somnolence, depression, and learning context.

Acronym

Effect of auricular acupuncture on somnolence.

Scientific Title

Effect of auricular acupuncture on somnolence, depression, and learning context.

Scientific Title:Acronym

Effect of auricular acupuncture on somnolence.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The present study aimed to investigate whether somnolence could change by auricular acupuncture in healthy subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

somnolence

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

auricular acupuncture

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

16 years-old <=

Age-upper limit

30 years-old >

Gender

Male and Female

Key inclusion criteria

1. Aged 20-29 years.
2. Person that informed consent was provided.

Key exclusion criteria

1. Person having a disease.
2. Person who takes medicine.
3. Current smokers

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Hideaki
Middle name
Last name Waki

Organization

University of Teikyoheise Faculty of Health Care

Division name

Department of acupuncture and Moxibustion.

Zip code

170-8445

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.

TEL

035-843-3111

Email

h.waki@thu.ac.jp


Public contact

Name of contact person

1st name Hideaki
Middle name Waki
Last name Waki

Organization

University of Teikyoheise Faculty of Health Care

Division name

Department of acupuncture and Moxibustion.

Zip code

170-8445

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.

TEL

035-843-3111

Homepage URL


Email

h.waki@thu.ac.jp


Sponsor or person

Institute

Teikyo Heisei University

Institute

Department

Personal name



Funding Source

Organization

Teikyo Heisei Universit

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo Heisei University

Address

Higashiikebukuro, Toshima-ku, Tokyo

Tel

03-5843-3111

Email

rec@thu.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

2020 Year 09 Month 01 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

10

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

2019 Year 03 Month 11 Day

Date of IRB

2019 Year 06 Month 01 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 02 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 23 Day

Last modified on

2020 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045136


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name