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

NCT04407351 | Completed DMC

• 1 other identifier: MOST106-3111-Y-043001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Sleep Disorder; Mild Cognitive Impairment; Phototherapy

Keywords

Dementia; Sleep Disorder; Phototherapy; Light Emitting Diode (LED); Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• Hydration

  Baseline

• Hydration

  12 weeks

• Hydration

  26 weeks

• Transepidermal water loss

  Baseline

• Transepidermal water loss

  12 weeks

Study Arms (2)

Arm Green LED light - Red LED light

OTHER

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.

Device: Green LED light; Device: Red LED light (placebo)

Arm Red LED light - Green LED light

OTHER

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.

Device: Green LED light; Device: Red LED light (placebo)

Interventions

Green LED light DEVICE

Investigators arrange 12 weeks green LED light phototherapy.

Arm Green LED light - Red LED light; Arm Red LED light - Green LED light

Red LED light (placebo) DEVICE

Investigators arrange 12 weeks red LED light phototherapy (placebo).

Arm Green LED light - Red LED light; Arm Red LED light - Green LED light

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dementia; Sleep Wake Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 29, 2020
• Study Start: May 1, 2017
• Primary Completion: April 30, 2020
• Study Completion: May 7, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)