We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses (t-PBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05146596
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : January 3, 2022
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to explore the treatment of Low Level Light Therapy(LLLT) mitigate possible insomnia and psychological symptoms, when nurses have taken shifts.The investigators hope that the goal of this interventional research is to improve sleep quality and psychological symptoms of shift nurses in order to promote health.

Condition or disease Intervention/treatment Phase
Shift Work Type Circadian Rhythm Sleep Disorder Device: use low level light therapy,The Dr.Tai's energy cap Not Applicable

Detailed Description:
Low-Level Light Therapy; LLLT is also called PhotoBioModulation; PBM, which is a new type of interventional therapy.LLLT applies low-level lasers or light-emitting diodes(LEDs) to the human body for treatment. The wavelength of irradiated light is between red light(630-700 nm) and near-infrared light(700nm-1,100nm), and leads to a positive biological effect. It is a safe, painless, non-invasive treatment method. When LLLT is applied to the brain, it can pass through the scalp, head bone and reach the brain, and then stimulating the photochemical reaction in the cells, This is called transcranial Low-Level Laser Therapy (t-LLLT) or transcranial Photobiomodulation(t-PBM). tLLLT has existed since 1967, and more than thousands of scientific studies have shown that photons can stimulate biological responses and promote the normal work of cells. t-LLLT can treat a variety of diseases, such as emotional symptoms, lower back pain, weight loss, skin anti-aging, wound healing, etc. There are no reports of side effects. The main mechanism is similar to the photosynthesis of plants. It absorbs light and produces chemical reactions, supports mitochondrial function, and significantly increases the production of ATP(the main carrier of energy in cells.)in the brain, so as to function work better and achieve self-repair. This research uses Dr. Tai's energy cap, the manufacturer is Topunion Globaltek Inc., which passed the certification of the Ministry of Health and Welfare(MOHW) for medical device in 2019. It has been modified to the second generation and is now on the market. It basically provides two kinds of red light (wavelength of 660nm) and near-infrared light(wavelength of 850nm), which is mainly used at home. The research intervention will be conducted for four weeks, pre-tests and post-tests will be conducted as indicators to evaluating sleep and psychological symptoms.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1.Registered nurses who consciously have insomnia and ISI>=9. 2. People who have clear consciousness, can understand and agree to participate in this research. 3. Registered nurses who have been on shifts in the past six months. 4. Have the same type of shift within the four weeks.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses：A Randomized-controlled Trial
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: LLLT group
use low level light therapy,The Dr.Tai's energy cap
 Device: use low level light therapy,The Dr.Tai's energy cap
30 minutes each time, three times a week, a total of 12 times.
No Intervention: control group
routine care.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. psychological symptoms [ Time Frame: 1 month,up to 4 weeks.measure every 1 week.Change from baseline DASS-21 at 1,2,3,4 weeks, a total of five times. ]
    use scale:Depression Anxiety Stress Scale-21(DASS-21)measure psychological symptoms.There are a total of 21 questions on the scale, each with a score of 3 and a score of 0 to 63. The higher score mean a worse outcome,mean psychological symptoms are severe.The higher the score the more severe the symptoms, the lower the score the more minor.


Secondary Outcome Measures :
  1. sleep symptoms [ Time Frame: 1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks. ]
    use scale:Insomnia Severity Index(ISI) measure sleep symptoms.There are a total of 7 questions on the scale, each with a score of 4 and a score of 0 to 28. The higher score mean a worse outcome,mean sleep symptoms are severe.The study measure use ISI scale every 2 weeks

  2. instrument:Heart rate variability(HRV) [ Time Frame: Measure three days a week, two time points (T0, T1) for each measurement, T0=baseline, and T1=after 30mins,24 times in both groups. ]
    heart rhythm variability and autonomic nerves, so this study used this instrument as an objective data collection.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Registered nurses who consciously have insomnia and ISI>=9.
  2. People who have clear consciousness, can understand and agree to participate in this research.
  3. Registered nurses who have been on shifts in the past six months.
  4. Have the same type of shift within the four weeks.

Exclusion Criteria:

  1. Those who have undergone head surgery.
  2. Those who are pregnant.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05146596


Contacts
Layout table for location contacts
Contact: Liao G Yung Hsuan 0910005317 yhliao3@vghtpe.gov.tw
Contact: Liao General Y Hsuan 0910005317 yhliao3@vghtpe.gov.tw

Locations
Layout table for location information
Taiwan
Liao General Yung Hsuan Recruiting
Taipei, Taiwan, 112
Contact: Liao General Y Hsuan, MD    0910005317    yhliao3@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Yang Ming University
Investigators
Layout table for investigator information
Principal Investigator: Liao General Y Hsuan Taipei Veterans General Hospital, Taiwan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT05146596    
Other Study ID Numbers: 2021-06-010C
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research is in progress and will not be published until it is completed.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Anxiety
Depression
nurses
LLLT
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
 Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases