<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04407351</url>
  </required_header>
  <id_info>
    <org_study_id>MOST106-3111-Y-043001</org_study_id>
    <nct_id>NCT04407351</nct_id>
  </id_info>
  <brief_title>Develop Novel Phototherapy for Health Care of Patients With Sleep Disorder, Mild Cognitive Impairment, or Dementia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators aim to collaborate with the division of neurology, ophthalmology and&#xD;
      dermatology at the Kaohsiung Medical University, and make a new phototherapy for participants&#xD;
      suffering from dementia, sleep disorder, mild cognitive dysfunction by using IoT and data&#xD;
      science on big health and environmental data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Solar light is an important environmental factor for all living organisms. With the&#xD;
      advancement of the lighting technology, artificial light, such as light emitting diode (LED),&#xD;
      has become another major lighting source. The influence of blue light and color temperature&#xD;
      emitted from LED light source in most of the commercial 3C electronics on human health has&#xD;
      been increasingly paid attention. Light exposure has been reported to be associated with&#xD;
      different physiological mechanisms and pathologic events, including sleeping, metabolism and&#xD;
      brain dysfunctions. However, lights are also applied in many therapeutic processes. Hence, it&#xD;
      is a critical issue to develop a next-generation lighting environment for health promotion&#xD;
      and improve the competitiveness of green-technology industries in Taiwan by integrating&#xD;
      biomedical researches and cutting-edge lighting technology. For developing next-generation&#xD;
      LED industry, the inspection technology and product standard on photobiology safety has been&#xD;
      established in Taiwan. Inspiringly, Researchers in Taiwan have made a LED structure that can&#xD;
      emit all the hues of sunlight by changing its terminal voltage, which may further facilitate&#xD;
      the use of future lighting device on health promotion. Based on these technical advancement,&#xD;
      in this project, investigators aim to integrate multidisciplinary investigations on animal&#xD;
      experiments, translational applications, and clinical trials to establish an good lighting&#xD;
      environment for participants with dementia and mild cognitive dysfunction, and bring benefits&#xD;
      to Taiwan's green technologies. To meet this goal, this project aims to integrate lighting&#xD;
      and information technologies, including Internet of Things (IoT) and data science analytics,&#xD;
      to investigate the lighting effects on human health by conducting animal and translational&#xD;
      experiments, and further promote the health in multiple testing groups across different&#xD;
      patients. In this project, investigators incorporate the research strengths in light&#xD;
      bioscience, environmental bioscience and medical engineering developed at National Health&#xD;
      Research Institutes (NHRI) and the lighting, IoT and data science technologies developed at&#xD;
      National Applied Research Laboratories (NARL). Additionally, investigators aim to collaborate&#xD;
      with the division of neurology, ophthalmology and dermatology at the Kaohsiung Medical&#xD;
      University, and make a new phototherapy for participants suffering from dementia, sleep&#xD;
      disorder, cognitive dysfunction by using IoT and data science on big health and environmental&#xD;
      data. By integrating multi-disciplinary technologies, investigators aim to promote health on&#xD;
      brain, mind and body for elderly people and susceptible population by providing a health home&#xD;
      lighting environment, which would be potentially beneficial to resolve the emerging issues of&#xD;
      aging, sub-health population, psychiatric and neurodegenerative diseases. Moreover, the&#xD;
      safety and molecular mechanism of phototherapy will be validated using animal models.&#xD;
      Industrially, this project will build a strong linkage between LED, information and health&#xD;
      promotion industries and upgrade the traditional LED industry by adding the novel application&#xD;
      on health promotion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">May 7, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laser Doppler blood flow analysis (perfusion unit (PU))</measure>
    <time_frame>Baseline</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laser Doppler blood flow analysis (perfusion unit (PU))</measure>
    <time_frame>12 weeks</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laser Doppler blood flow analysis (perfusion unit (PU))</measure>
    <time_frame>26 weeks</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hydration</measure>
    <time_frame>Baseline</time_frame>
    <description>The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hydration</measure>
    <time_frame>12 weeks</time_frame>
    <description>The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hydration</measure>
    <time_frame>26 weeks</time_frame>
    <description>The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal water loss</measure>
    <time_frame>Baseline</time_frame>
    <description>Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal water loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal water loss</measure>
    <time_frame>26 weeks</time_frame>
    <description>Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sebum</measure>
    <time_frame>Baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sebum</measure>
    <time_frame>12 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sebum</measure>
    <time_frame>26 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Dementia</condition>
  <condition>Sleep Disorder</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Phototherapy</condition>
  <arm_group>
    <arm_group_label>Arm Green LED light - Red LED light</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Red LED light - Green LED light</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Green LED light</intervention_name>
    <description>Investigators arrange 12 weeks green LED light phototherapy.</description>
    <arm_group_label>Arm Green LED light - Red LED light</arm_group_label>
    <arm_group_label>Arm Red LED light - Green LED light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Red LED light (placebo)</intervention_name>
    <description>Investigators arrange 12 weeks red LED light phototherapy (placebo).</description>
    <arm_group_label>Arm Green LED light - Red LED light</arm_group_label>
    <arm_group_label>Arm Red LED light - Green LED light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) The age is between 55 and 80 years old&#xD;
&#xD;
          -  (2) Education level is above elementary school graduation&#xD;
&#xD;
          -  (3) Use Edinburgh Inventory as the right hand&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Neurological diseases, including cerebral stroke, epilepsy, Parkinson's disease&#xD;
             and head trauma that cause local nerve signs&#xD;
&#xD;
          -  (2) Mental illnesses, including mental disorders, drug addiction, abnormal&#xD;
             personality, and poorly controlled schizophrenia;&#xD;
&#xD;
          -  (3) Regularly take sedative and sleeping drugs or central nervous system stimulants&#xD;
&#xD;
          -  (4) Major physical diseases, including cancer, poorly controlled diabetes,&#xD;
             hypertension and thyroid disease, immune rheumatism, heart failure, chronic&#xD;
             obstructive pulmonary disease, liver cirrhosis, and chronic kidney disease stages IV&#xD;
             and V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Medical University Hospital</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <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>
    <PMID>21087230</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26123172</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Medical University</investigator_affiliation>
    <investigator_full_name>Hsin-Su Yu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Sleep Disorder</keyword>
  <keyword>Phototherapy</keyword>
  <keyword>Light Emitting Diode (LED)</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Investigators do not plan to make individual participant data available to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04407351
org study id: MOST106-3111-Y-043001
nct id: NCT04407351
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Laser Doppler blood flow analysis (perfusion unit (PU))
time frame: Baseline
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).
measure: Laser Doppler blood flow analysis (perfusion unit (PU))
time frame: 12 weeks
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).
measure: Laser Doppler blood flow analysis (perfusion unit (PU))
time frame: 26 weeks
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).
measure: Hydration
time frame: Baseline
description: The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
measure: Hydration
time frame: 12 weeks
description: The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
measure: Hydration
time frame: 26 weeks
description: The skin multi-functional detection system measures the skin's water content to detect whether the skin is too dry.
measure: Transepidermal water loss
time frame: Baseline
description: Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
measure: Transepidermal water loss
time frame: 12 weeks
description: Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
measure: Transepidermal water loss
time frame: 26 weeks
description: Use the skin multifunctional detection system to measure the skin water loss state to understand the skin health.
measure: Sebum
time frame: Baseline
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.
measure: Sebum
time frame: 12 weeks
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.
measure: Sebum
time frame: 26 weeks
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.
arm group label: Arm Green LED light - Red LED light
arm group type: Other
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 group label: Arm Red LED light - Green LED light
arm group type: Other
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: Green LED light
description: Investigators arrange 12 weeks green LED light phototherapy.
arm group label: Arm Green LED light - Red LED light
arm group label: Arm Red LED light - Green LED light
intervention type: Device
intervention name: Red LED light (placebo)
description: Investigators arrange 12 weeks red LED light phototherapy (placebo).
arm group label: Arm Green LED light - Red LED light
arm group label: Arm Red LED light - Green LED light
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
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.
PMID: 21087230
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.
PMID: 26123172
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Medical University
investigator full name: Hsin-Su Yu
investigator title: Professor
mesh term: Dementia
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: Investigators do not plan to make individual participant data available to other researchers.