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

November 25, 2025 updated by: Wan-Ju Cheng, China Medical University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bright light
Device: Bright light
Bright light will use a 5000-10,000 Lux LED light source. Exposure is for 60 minutes daily, between 7pm and 9pm.
Active Comparator: Near-infrared light
Device: Near-infrared light
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.
Active Comparator: Bright light+ near-infrared light
Device: Bright light+ near-infrared light
After using the bright light device, then use the near-infrared light device on the back of the neck before going to bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and the third week.
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.
Baseline and the third week.
Sleep quality
Time Frame: Baseline and the third week.
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).
Baseline and the third week.
Emotional state
Time Frame: Baseline and the third week.
Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).
Baseline and the third week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daytime sleepiness
Time Frame: Baseline and the third week.
Epworth Sleepiness Scale ranges from 0 (better) to 24 (worse).
Baseline and the third week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

October 3, 2025

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC2-214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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