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

Not Applicable

Recruiting

• Conditions: Photobiomodulation

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Pittsburgh Sleep Quality Index score is 8 or above.<br><br> - Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30<br> minutes, lasting for more than 3 months.<br><br>Exclusion Criteria:<br><br> - Movement disorder, inability to move independently.<br><br> - Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may<br> cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).<br><br> - Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.<br><br> - Bipolar disorder.<br><br> - Light-induced epilepsy.<br><br> - Sleep disorders such as sleep apnea and involuntary leg twitching.<br><br> - Currently taking sedative-hypnotic drugs or receiving other non-drug treatments.<br><br> - Beck depression inventory-II score is greater than 13 points.<br><br> - Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers.<br><br> - Acute illness.<br><br> - Abnormal blood pressure or fever.<br><br> - Pregnancy and pregnant women.<br><br> - Special physical abnormalities and sensory nerve abnormalities.<br><br> - Infectious diseases.<br><br> - Coagulation disorder.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Actigraphy-derived sleep indicators;Dim-light melatonin onset;Sleep quality;Emotional state

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness