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

Not Applicable

Recruiting

• Conditions: Photobiomodulation
• Interventions: Device: Bright light; Device: Bright light+ near-infrared light; Device: Near-infrared light

• Registration Number: NCT06292819
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Study Start: 2024-04-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright light	Bright light	-
Bright light+ near-infrared light	Bright light+ near-infrared light	-
Near-infrared light	Near-infrared light	-

Primary Outcome Measures

Name	Time	Method
Actigraphy-derived sleep indicators	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.
Sleep quality	Baseline and the third week.	Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).
Dim-light melatonin onset	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.
Emotional state	Baseline and the third week.	Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness	Baseline and the third week.	Epworth Sleepiness Scale ranges from 0 (better) to 24 (worse).

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan