UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055509
Receipt number R000063408
Scientific Title The effect of collaborative activities in video communication on cognitive fatigue
Date of disclosure of the study information 2024/09/16
Last modified on 2024/09/16 08:10:13

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Basic information

Public title

The effect of collaborative activities in video communication on cognitive fatigue

Acronym

The effect of collaborative activities in video communication on cognitive fatigue

Scientific Title

The effect of collaborative activities in video communication on cognitive fatigue

Scientific Title:Acronym

The effect of collaborative activities in video communication on cognitive fatigue

Region

Japan


Condition

Condition

Adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will investigate the effect of collaborative activities via video communication on cognitive .

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fatigue (VAS, Go-Nogo task, fNIRS)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Cooperation task in face-to-tace communication

Interventions/Control_2

Cooperation task in video communication

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

18 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

Right-handed healthy adults

Key exclusion criteria

We will exclude subjects with a history of mental disorders or cranial nerve diseases, those with visual or hearing impairments that prevent task performance, those with chronic fatigue, those who have taken supplements or medication for fatigue, those with sleep disorders, and smokers.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Tsuchiya

Organization

Nagano University of Health and Medicine

Division name

Department of Rehabilitation

Zip code

381-2227

Address

11-1 Imaihara-Kawanakajima, Nagano, Nagano

TEL

026-283-6111

Email

tsuchiya.kenji@shitoku.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Tsuchiya

Organization

Nagano University of Health and Medicine

Division name

Department of Rehabilitation

Zip code

381-2227

Address

11-1 Imaihara-Kawanakajima, Nagano, Nagano

TEL

026-283-6111

Homepage URL


Email

tsuchiya.kenji@shitoku.ac.jp


Sponsor or person

Institute

Nagano University of Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Nagano University of Health and Medicine

Address

11-1 Imaihara-Kawanakajima, Nagano, Nagano

Tel

026-283-6111

Email

Non


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

2024 Year 09 Month 16 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

Open public recruiting

Date of protocol fixation

2024 Year 06 Month 25 Day

Date of IRB

2024 Year 09 Month 09 Day

Anticipated trial start date

2024 Year 09 Month 16 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 09 Month 16 Day

Last modified on

2024 Year 09 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063408