NCT06292819

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2024-04-26
• Primary completion: 2025-08-31
• Completion: 2025-10-03
• First posted: 2024-03-05
• Last updated: 2025-12-02

Locations

1 site across 1 country: Taiwan