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

NCT06292819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-26
Primary Completion
2025-08-31
Completion
2025-10-03

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06292819 on ClinicalTrials.gov