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Develop Novel Phototherapy for Health Care of Patients With Sleep Disorder, Mild Cognitive Impairment, or Dementia

Primary Purpose

Dementia, Sleep Disorder, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Green LED light
Red LED light (placebo)
Sponsored by
Kaohsiung Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Dementia, Sleep Disorder, Phototherapy, Light Emitting Diode (LED), Mild Cognitive Impairment

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (1) The age is between 55 and 80 years old
  • (2) Education level is above elementary school graduation
  • (3) Use Edinburgh Inventory as the right hand

Exclusion Criteria:

  • (1) Neurological diseases, including cerebral stroke, epilepsy, Parkinson's disease and head trauma that cause local nerve signs
  • (2) Mental illnesses, including mental disorders, drug addiction, abnormal personality, and poorly controlled schizophrenia;
  • (3) Regularly take sedative and sleeping drugs or central nervous system stimulants
  • (4) Major physical diseases, including cancer, poorly controlled diabetes, hypertension and thyroid disease, immune rheumatism, heart failure, chronic obstructive pulmonary disease, liver cirrhosis, and chronic kidney disease stages IV and V

Sites / Locations

  • Kaohsiung Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm Green LED light - Red LED light

Arm Red LED light - Green LED light

Arm Description

Every morning between 7-8 o'clock, participants will receive 7,500 Lux at home at 470 nm as a full-band (bright light) light-emitting diode (Green LED light) luminaire with a distance of 80-100 cm at a 45-degree angle Light exposure for 30-60 minutes for 12 weeks, the rest of the time indoors is not limited by light. Then crossover to red light after 2 weeks for wash out. Every morning between 7-8 o'clock, participants receive 50 Lux of Red LED light (dim light) at their own homes and illuminate at a distance of 80-100 cm at a 45-degree angle for 30-60 minutes for 12 weeks.

Every morning between 7-8 o'clock, participants receive 50 Lux of Red LED light (dim light) at their own homes and illuminate at a distance of 80-100 cm at a 45-degree angle for 30-60 minutes for 12 weeks, and the rest of the time indoors is not restricted by light. Then crossover to green light after 2 weeks for wash out. Every morning between 7-8 o'clock, participants will receive 7,500 Lux at home at 470 nm as a full-band (bright light) light-emitting diode (Green LED light) luminaire with a distance of 80-100 cm at a 45-degree angle Light exposure for 30-60 minutes for 12 weeks.

Outcomes

Primary Outcome Measures

Laser Doppler blood flow analysis (perfusion unit (PU))
It is a technique for monitoring microvascular perfusion by PeriFlux System 5000 (Perimed, Stockholm, Sweden). The light source can penetrate tissues and thus can measure blood perfusion without invasive procedures. The microvascular perfusion situation is immediate results and can be used to quantify the degree of skin damage. Its unit is perfusion unit (PU).
Laser Doppler blood flow analysis (perfusion unit (PU))
It is a technique for monitoring microvascular perfusion by PeriFlux System 5000 (Perimed, Stockholm, Sweden). The light source can penetrate tissues and thus can measure blood perfusion without invasive procedures. The microvascular perfusion situation is immediate results and can be used to quantify the degree of skin damage. Its unit is perfusion unit (PU).
Laser Doppler blood flow analysis (perfusion unit (PU))
It is a technique for monitoring microvascular perfusion by PeriFlux System 5000 (Perimed, Stockholm, Sweden). The light source can penetrate tissues and thus can measure blood perfusion without invasive procedures. The microvascular perfusion situation is immediate results and can be used to quantify the degree of skin damage. Its unit is perfusion unit (PU).

Secondary Outcome Measures

Hydration
The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
Hydration
The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
Hydration
The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
Transepidermal water loss
Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
Transepidermal water loss
Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
Transepidermal water loss
Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
Sebum
The measuring principle is to use a photometer to measure the oil point transmittance to determine the size of the oil point and detect the skin oil content.
Sebum
The measuring principle is to use a photometer to measure the oil point transmittance to determine the size of the oil point and detect the skin oil content.
Sebum
The measuring principle is to use a photometer to measure the oil point transmittance to determine the size of the oil point and detect the skin oil content.

Full Information

First Posted
May 10, 2020
Last Updated
May 27, 2020
Sponsor
Kaohsiung Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04407351
Brief Title
Develop Novel Phototherapy for Health Care of Patients With Sleep Disorder, Mild Cognitive Impairment, or Dementia
Official Title
Develop Phototherapy of Improving the Quality of Sleep and Healthcare for Patients With Sleep Disorder, Mild Cognitive Impairment, or Dementia: a Novel Light Emitting Diode (LED) Application on Health Promotion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators aim to collaborate with the division of neurology, ophthalmology and dermatology at the Kaohsiung Medical University, and make a new phototherapy for participants suffering from dementia, sleep disorder, mild cognitive dysfunction by using IoT and data science on big health and environmental data.
Detailed Description
Solar light is an important environmental factor for all living organisms. With the advancement of the lighting technology, artificial light, such as light emitting diode (LED), has become another major lighting source. The influence of blue light and color temperature emitted from LED light source in most of the commercial 3C electronics on human health has been increasingly paid attention. Light exposure has been reported to be associated with different physiological mechanisms and pathologic events, including sleeping, metabolism and brain dysfunctions. However, lights are also applied in many therapeutic processes. Hence, it is a critical issue to develop a next-generation lighting environment for health promotion and improve the competitiveness of green-technology industries in Taiwan by integrating biomedical researches and cutting-edge lighting technology. For developing next-generation LED industry, the inspection technology and product standard on photobiology safety has been established in Taiwan. Inspiringly, Researchers in Taiwan have made a LED structure that can emit all the hues of sunlight by changing its terminal voltage, which may further facilitate the use of future lighting device on health promotion. Based on these technical advancement, in this project, investigators aim to integrate multidisciplinary investigations on animal experiments, translational applications, and clinical trials to establish an good lighting environment for participants with dementia and mild cognitive dysfunction, and bring benefits to Taiwan's green technologies. To meet this goal, this project aims to integrate lighting and information technologies, including Internet of Things (IoT) and data science analytics, to investigate the lighting effects on human health by conducting animal and translational experiments, and further promote the health in multiple testing groups across different patients. In this project, investigators incorporate the research strengths in light bioscience, environmental bioscience and medical engineering developed at National Health Research Institutes (NHRI) and the lighting, IoT and data science technologies developed at National Applied Research Laboratories (NARL). Additionally, investigators aim to collaborate with the division of neurology, ophthalmology and dermatology at the Kaohsiung Medical University, and make a new phototherapy for participants suffering from dementia, sleep disorder, cognitive dysfunction by using IoT and data science on big health and environmental data. By integrating multi-disciplinary technologies, investigators aim to promote health on brain, mind and body for elderly people and susceptible population by providing a health home lighting environment, which would be potentially beneficial to resolve the emerging issues of aging, sub-health population, psychiatric and neurodegenerative diseases. Moreover, the safety and molecular mechanism of phototherapy will be validated using animal models. Industrially, this project will build a strong linkage between LED, information and health promotion industries and upgrade the traditional LED industry by adding the novel application on health promotion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Sleep Disorder, Mild Cognitive Impairment, Phototherapy
Keywords
Dementia, Sleep Disorder, Phototherapy, Light Emitting Diode (LED), Mild Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Green LED light - Red LED light
Arm Type
Other
Arm Description
Every morning between 7-8 o'clock, participants will receive 7,500 Lux at home at 470 nm as a full-band (bright light) light-emitting diode (Green LED light) luminaire with a distance of 80-100 cm at a 45-degree angle Light exposure for 30-60 minutes for 12 weeks, the rest of the time indoors is not limited by light. Then crossover to red light after 2 weeks for wash out. Every morning between 7-8 o'clock, participants receive 50 Lux of Red LED light (dim light) at their own homes and illuminate at a distance of 80-100 cm at a 45-degree angle for 30-60 minutes for 12 weeks.
Arm Title
Arm Red LED light - Green LED light
Arm Type
Other
Arm Description
Every morning between 7-8 o'clock, participants receive 50 Lux of Red LED light (dim light) at their own homes and illuminate at a distance of 80-100 cm at a 45-degree angle for 30-60 minutes for 12 weeks, and the rest of the time indoors is not restricted by light. Then crossover to green light after 2 weeks for wash out. Every morning between 7-8 o'clock, participants will receive 7,500 Lux at home at 470 nm as a full-band (bright light) light-emitting diode (Green LED light) luminaire with a distance of 80-100 cm at a 45-degree angle Light exposure for 30-60 minutes for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Green LED light
Intervention Description
Investigators arrange 12 weeks green LED light phototherapy.
Intervention Type
Device
Intervention Name(s)
Red LED light (placebo)
Intervention Description
Investigators arrange 12 weeks red LED light phototherapy (placebo).
Primary Outcome Measure Information:
Title
Laser Doppler blood flow analysis (perfusion unit (PU))
Description
It is a technique for monitoring microvascular perfusion by PeriFlux System 5000 (Perimed, Stockholm, Sweden). The light source can penetrate tissues and thus can measure blood perfusion without invasive procedures. The microvascular perfusion situation is immediate results and can be used to quantify the degree of skin damage. Its unit is perfusion unit (PU).
Time Frame
Baseline
Title
Laser Doppler blood flow analysis (perfusion unit (PU))
Description
It is a technique for monitoring microvascular perfusion by PeriFlux System 5000 (Perimed, Stockholm, Sweden). The light source can penetrate tissues and thus can measure blood perfusion without invasive procedures. The microvascular perfusion situation is immediate results and can be used to quantify the degree of skin damage. Its unit is perfusion unit (PU).
Time Frame
12 weeks
Title
Laser Doppler blood flow analysis (perfusion unit (PU))
Description
It is a technique for monitoring microvascular perfusion by PeriFlux System 5000 (Perimed, Stockholm, Sweden). The light source can penetrate tissues and thus can measure blood perfusion without invasive procedures. The microvascular perfusion situation is immediate results and can be used to quantify the degree of skin damage. Its unit is perfusion unit (PU).
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Hydration
Description
The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
Time Frame
Baseline
Title
Hydration
Description
The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
Time Frame
12 weeks
Title
Hydration
Description
The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
Time Frame
26 weeks
Title
Transepidermal water loss
Description
Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
Time Frame
Baseline
Title
Transepidermal water loss
Description
Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
Time Frame
12 weeks
Title
Transepidermal water loss
Description
Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
Time Frame
26 weeks
Title
Sebum
Description
The measuring principle is to use a photometer to measure the oil point transmittance to determine the size of the oil point and detect the skin oil content.
Time Frame
Baseline
Title
Sebum
Description
The measuring principle is to use a photometer to measure the oil point transmittance to determine the size of the oil point and detect the skin oil content.
Time Frame
12 weeks
Title
Sebum
Description
The measuring principle is to use a photometer to measure the oil point transmittance to determine the size of the oil point and detect the skin oil content.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (1) The age is between 55 and 80 years old (2) Education level is above elementary school graduation (3) Use Edinburgh Inventory as the right hand Exclusion Criteria: (1) Neurological diseases, including cerebral stroke, epilepsy, Parkinson's disease and head trauma that cause local nerve signs (2) Mental illnesses, including mental disorders, drug addiction, abnormal personality, and poorly controlled schizophrenia; (3) Regularly take sedative and sleeping drugs or central nervous system stimulants (4) Major physical diseases, including cancer, poorly controlled diabetes, hypertension and thyroid disease, immune rheumatism, heart failure, chronic obstructive pulmonary disease, liver cirrhosis, and chronic kidney disease stages IV and V
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Investigators do not plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
21087230
Citation
Yu WT, Yu HS, Wu CS, Lee CH, Cheng YC, Lin WT, Chen GS, Lan CC. Noninvasive cutaneous blood flow as a response predictor for visible light therapy on segmental vitiligo: a prospective pilot study. Br J Dermatol. 2011 Apr;164(4):759-64. doi: 10.1111/j.1365-2133.2010.10148.x.
Results Reference
background
PubMed Identifier
26123172
Citation
Yang SY, Lan CC. Acquired Port-wine Stain with Local Heat. Acta Derm Venereol. 2016 Feb;96(2):274-5. doi: 10.2340/00015555-2193. No abstract available.
Results Reference
background

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Develop Novel Phototherapy for Health Care of Patients With Sleep Disorder, Mild Cognitive Impairment, or Dementia

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