Clinical trial NCT04407351: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Sleep Disorder
Mild Cognitive Impairment
Phototherapy
Keywords: Dementia
Sleep Disorder
Phototherapy
Light Emitting Diode (LED)
Mild Cognitive Impairment
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 51
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Laser Doppler blood flow analysis (perfusion unit (PU))
timeFrame: Baseline
measure: Laser Doppler blood flow analysis (perfusion unit (PU))
timeFrame: 12 weeks
measure: Laser Doppler blood flow analysis (perfusion unit (PU))
timeFrame: 26 weeks
Secondary outcomes:
measure: Hydration
timeFrame: Baseline
measure: Hydration
timeFrame: 12 weeks
measure: Hydration
timeFrame: 26 weeks
measure: Transepidermal water loss
timeFrame: Baseline
measure: Transepidermal water loss
timeFrame: 12 weeks
measure: Transepidermal water loss
timeFrame: 26 weeks
measure: Sebum
timeFrame: Baseline
measure: Sebum
timeFrame: 12 weeks
measure: Sebum
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
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.
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.