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NCT Number: NCT06292819

Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices

The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.

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Key information

Conditions

Photobiomodulation Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pittsburgh Sleep Quality Index score is 8 or above.
  • Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.

Exclusion criteria

  • Movement disorder, inability to move independently.
  • Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).
  • Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.
  • Bipolar disorder.
  • Light-induced epilepsy.
  • Sleep disorders such as sleep apnea and involuntary leg twitching.
  • Currently taking sedative-hypnotic drugs or receiving other non-drug treatments.
  • Beck depression inventory-II score is greater than 13 points.
  • Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers.
  • Acute illness.
  • Abnormal blood pressure or fever.
  • Pregnancy and pregnant women.
  • Special physical abnormalities and sensory nerve abnormalities.
  • Infectious diseases.
  • Coagulation disorder.

Treatment and study plan

Bright light

Device

Bright light will use a 5000-10,000 Lux LED light source. Exposure is for 60 minutes daily, between 7pm and 9pm.

Near-infrared light

Device

Near-infrared light will use a wavelength of 850nm and a dose range of 1 - 6.5 joules/cm2. It is fixed on the neck with a band, the light source contacts the back of the neck, and is used for 60 minutes before going to bed.

Bright light+ near-infrared light

Device

After using the bright light device, then use the near-infrared light device on the back of the neck before going to bed.

Primary outcomes

  1. Actigraphy-derived sleep indicators

    Time frame: Baseline and the third week.

    Participants will continue to wear activity recording watches during the three weeks of the study. We will capture weekly average sleep duration, sleep onset latency, wake time after falling asleep, and sleep efficiency.

  2. Dim-light melatonin onset

    Time frame: Baseline and the third week.

    Participants will be required to provide saliva samples for melatonin analysis within their home environment. These samples will be collected at 30-minute intervals starting from 18:00 and continuing until 1 hour after their habitual sleep time on both the initial and final study dates. The concentration of salivary melatonin will be assessed utilizing a direct melatonin enzyme-linked immunosorbent assay (ELISA) kit. The Dim Light Melatonin Onset (DLMO) will be determined using the two standard deviation threshold method, which involves calculating the average of the first three melatonin data points and then adding two standard deviations to this average.

  3. Sleep quality

    Time frame: Baseline and the third week.

    Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).

  4. Emotional state

    Time frame: Baseline and the third week.

    Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).

Secondary outcomes

  1. Daytime sleepiness

    Time frame: Baseline and the third week.

    Epworth Sleepiness Scale ranges from 0 (better) to 24 (worse).

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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