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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2025-10-03

Brief Summary

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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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Detailed Description

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Conditions

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Photobiomodulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bright light

Group Type ACTIVE_COMPARATOR

Bright light

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Near-infrared light

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Bright light+ near-infrared light

Intervention Type DEVICE

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

Interventions

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Bright light

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No