What is 40 Hz flicker light stimulation studying for Parkinson's disease insomnia?

This study is evaluating whether 40 Hz flicker light stimulation can improve insomnia symptoms in Parkinson's disease patients. Researchers are comparing this light treatment to a control light to assess its effects on sleep quality and other non-motor symptoms. The trial is sponsored by Jiangsu Province Nanjing Brain Hospital and aims to find new non-drug approaches for sleep problems in PD.

Who may be eligible for this Parkinson's disease insomnia clinical trial?

Adults aged 50 to 75 years diagnosed with Parkinson's disease and experiencing clinically significant insomnia may be eligible. Participants must have stable Parkinson's medication for at least 4 weeks and meet specific sleep disturbance criteria. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this Parkinson's disease insomnia clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel or other expenses for participating may vary and are not guaranteed to be covered. Participants should consider these factors when joining the trial.

Actively Recruiting

Phase Not Applicable

Age: 50Years - 75Years

All Genders

ID07323121

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

Led by Jiangsu Province Nanjing Brain Hospital · Updated on 2026-07-28

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

40 Hz Flickering for Insomnia in Parkinson's Disease

Who Can Participate

Age: 50Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of Parkinson's disease according to established clinical criteria
Age between 50 and 75 years
Disease duration 10 years or less and Hoehn and Yahr stage 3 or less in the "on" state
Clinically significant insomnia with PDSS-2 total score 18 points or higher and/or meeting insomnia diagnostic criteria
Stable antiparkinsonian medication for at least 4 weeks before enrollment
Able and willing to comply with study procedures and provide written informed consent

You will not qualify if you...

Secondary insomnia due to severe systemic diseases, major psychiatric disorders, or substance abuse
History of epilepsy, photosensitive seizures, photosensitive dermatitis, or other contraindications to flicker light
Severe visual impairment or eye diseases interfering with light stimulation or safety
Unstable or severe medical conditions making participation unsafe
Participation in another interventional trial within the past 3 months
Inability to complete study procedures or follow-up due to cognitive, physical, or social reasons

Research Team

Haochen Sun, MD

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