CClinicalTrials.gg
Status unknownNCT05146596t-PBMUpdated Jan 3, 2022

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

An interventional study of use low level light therapy,The Dr.Tai's energy cap in Shift Work Type Circadian Rhythm Sleep Disorder, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Shift Work Type Circadian Rhythm Sleep Disorder

Keywords

  • Anxiety
  • Depression
  • nurses
  • LLLT
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In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's planned enrollment of 160 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Those who have undergone head surgery.
  2. Those who are pregnant.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • 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

  • No intervention
    control group

    routine care.

Interventions

  • Deviceuse low level light therapy,The Dr.Tai's energy cap

    30 minutes each time, three times a week, a total of 12 times.

06

What researchers measure

Primary outcomes

  1. psychological symptoms

    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.

    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.

Secondary outcomes

  1. sleep symptoms

    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

    Time frame: 1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.

  2. instrument:Heart rate variability(HRV)

    heart rhythm variability and autonomic nerves, so this study used this instrument as an objective data collection.

    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.

07

Study locations

1 of 1 sites recruiting
  • Liao General Yung Hsuan
    Taipei, 112, Taiwan
    Recruiting
08

References and documents

Publications

  • Hamblin MR. Photobiomodulation or low-level laser therapy. J Biophotonics. 2016 Dec;9(11-12):1122-1124. doi: 10.1002/jbio.201670113. No abstract available. PubMed 27973730 ↗

Individual participant data

Plan to share: No — The research is in progress and will not be published until it is completed.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05146596
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming Chiao Tung University
Responsible party
Sponsor
First posted
Dec 7, 2021
Start date
Jul 1, 2021
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Jan 3, 2022

Study contacts

Liao G Yung Hsuan
Contact
yhliao3@vghtpe.gov.tw
0910005317
Liao General Y Hsuan
Contact
yhliao3@vghtpe.gov.tw
0910005317
Liao General Y Hsuan
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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