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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407351
• Other study ID #: MOST106-3111-Y-043001
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 7, 2020

Study information

• Verified date: May 2020
• Source: Kaohsiung Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 7, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Disease
• Mild Cognitive Impairment
• Parasomnias
• Phototherapy
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Green LED light
Investigators arrange 12 weeks green LED light phototherapy.
• Red LED light (placebo)
Investigators arrange 12 weeks red LED light phototherapy (placebo).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	12 weeks
Primary	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).	26 weeks
Secondary	Hydration	The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.	Baseline
Secondary	Hydration	The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.	12 weeks
Secondary	Hydration	The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.	26 weeks
Secondary	Transepidermal water loss	Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.	Baseline
Secondary	Transepidermal water loss	Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.	12 weeks
Secondary	Transepidermal water loss	Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.	26 weeks
Secondary	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.	Baseline
Secondary	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.	12 weeks
Secondary	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.	26 weeks