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

NCT06292819 | Completed

• 1 other identifier: CMUH112-REC2-214
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Photobiomodulation

Keywords

rhythm; light therapy; insomnia; sleep; older

Outcome Measures

Primary Outcomes (4)

• Actigraphy-derived sleep indicators

  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

  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

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

  Baseline and the third week.

• Emotional state

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

  Baseline and the third week.

Secondary Outcomes (1)

• Daytime sleepiness

  Baseline and the third week.

Study Arms (3)

Bright light

ACTIVE COMPARATOR

Device: Bright light

Near-infrared light

ACTIVE COMPARATOR

Device: Near-infrared light

Bright light+ near-infrared light

ACTIVE COMPARATOR

Device: Bright light+ near-infrared light

Interventions

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.

Bright light

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.

Near-infrared light

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.

Bright light+ near-infrared light

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 5, 2024
• Study Start: April 26, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 3, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)