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

Photobiomodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292819
• Other study ID #: CMUH112-REC2-214
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: China Medical University Hospital
• Contact: Cheng, Ph.D.
• Phone: +886422052121
• Email: s871065[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Photobiomodulation
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).	Baseline and the third week.
Primary	Emotional state	Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).	Baseline and the third week.
Secondary	Daytime sleepiness	Epworth Sleepiness Scale ranges from 0 (better) to 24 (worse).	Baseline and the third week.