Lighting and Human Response in Motor Time, Autonomic Nerv... | NCT03144791

Studies
Lighting and Human Response in Motor Time, Autonomic Nervous System, and Emotion

NCT03144791

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

May 9, 2017Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Physical Activity
Emotions
Autonomic Nervous System Imbalance

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2017Estimated

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

May 5, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2017

Last Update Posted Date

May 9, 2017Actual

Name	Class
Chulalongkorn University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Light influences on human movement, autonomic nervous system, and emotion. It is inconclusive whether illuminance (Ev) and colour temperature (Tc) is appropriate to human movement, autonomic nervous systme, and emotion. Effect of Ev and Tc on responses of movement, autonomic nervous system, and emotion in human is investigated.

Detailed Description

The adult and elderly sign informed consent form. They sit in a room where Ev and Tc is adjusted. During sitting they are measured response of movement, autonomic nervous system, and emotion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
elderly , young adults		Participants are in 9 light conditions, 5 minute for each condition.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
motor response time	ms	1 minute

Secondary Outcomes

Measure	Description	Time Frame
Brain activity	microvolt	5 minutes
Heart rate variability	millisecond	2 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18 - 79 years old
Normal visual acuity with or without own glasses or contact lens
Normal visual field
Normal visual color perception
Able to following commands
Able to read, write, and understand in Thai language
Able to sit independently with or without support
Able to move dominant upper limb
No pain in dominant Shoulder, Elbow, Wrist, and Hand during movement

Exclusion Criteria:

Aggravated pain at trunk and lower limb during movement of dominant upper limb
Having Neurological disorders
Having uncontrolled diseases
Having psychological problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vimonwan Hiengkaew, PhD	Contact	+6624415450		vimonwan.hie@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Vimonwan Hiengkaew, PhD	Mahidol University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26192281	Background	Kuijsters A, Redi J, de Ruyter B, Heynderickx I. Lighting to Make You Feel Better: Improving the Mood of Elderly People with Affective Ambiences. PLoS One. 2015 Jul 20;10(7):e0132732. doi: 10.1371/journal.pone.0132732. eCollection 2015.
23099814	Background	Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645.