Study of 40 Hz Flicker Light Therapy for Insomnia and Sleep Problems in Parkinsons Disease Patients Aged 50 to 75

What this Trial Is About

This trial investigates the use of 40 Hz flicker light stimulation to address insomnia in patients with Parkinsons disease PD, a condition marked by motor and non-motor symptoms including sleep disturbances. Current drug treatments for PD-related insomnia may not be sufficient and can cause side effects, so this study explores a non-drug method that may influence brain activity related to sleep regulation. Approximately 30 patients with PD and significant insomnia symptoms will participate in this randomized, single-blind, controlled study. Participants will be randomly assigned to one of two groups one receiving 40 Hz flicker light stimulation and the other receiving 100 Hz control light. Both groups will receive the light for 30 minutes each night at bedtime for seven consecutive nights, alongside their stable Parkinsons medication. The flicker light is delivered using a specialized device with parameters adjusted for safety and comfort. The study focuses specifically on this PD insomnia group within a larger parent protocol. Throughout the trial, participants will complete sleep assessments including the Parkinsons Disease Sleep Scale-2 PDSS-2, sleep quality questionnaires, and sleep diaries. Objective sleep measures such as total sleep time and awakenings will be collected using polysomnography when possible. Other non-motor symptoms will also be evaluated. Safety will be monitored through adverse event tracking, vital signs, and checking for any visual discomfort. The primary outcome is the change in PDSS-2 score from baseline to Day 7, with additional follow-up assessments conducted at Day 28.

40 Hz Flickering for Insomnia in Parkinson's Disease