40 Hz flicker light for sleep in Parkinson’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind, controlled trial will compare 40 Hz flicker light stimulation to a non-40 Hz control light for 30 minutes each night for 7 days in adults with Parkinson’s disease and clinically significant insomnia. All participants will continue their standard Parkinson’s medications. The main outcome is change in sleep as measured by the Parkinson’s Disease Sleep Scale-2 (PDSS-2); secondary outcomes include objective sleep parameters from sleep studies, self-reported sleep quality, and other non-motor symptoms, with safety and tolerability monitored throughout. The study is conducted at a single center and is part of a larger multi-cohort protocol focusing on non-pharmacological sleep interventions in PD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of Parkinson's disease according to established clinical criteria (e.g., Movement Disorder Society criteria).
* Age between 50 and 75 years.
* Disease duration ≤ 10 years and Hoehn and Yahr stage ≤ 3 in the "on" state.
* Clinically significant insomnia, defined as Parkinson's Disease Sleep Scale-2 (PDSS-2) total score ≥ 18 points and/or meeting diagnostic criteria for insomnia.
* Stable antiparkinsonian medication regimen for at least 4 weeks prior to enrollment.
* Able and willing to comply with study procedures and provide written informed consent.

Exclusion Criteria:

* Secondary insomnia primarily due to severe systemic diseases or major psychiatric disorders (e.g., psychosis, severe depression or anxiety) or substance abuse.
* History of epilepsy, photosensitive seizures, photosensitive dermatitis, or other conditions in which flicker light stimulation is contraindicated.
* Severe visual impairment or eye diseases that would interfere with light stimulation or safety assessment.
* Unstable or severe medical conditions (e.g., uncontrolled cardiovascular, hepatic, renal, or endocrine disease) that, in the investigator's opinion, make participation unsafe.
* Participation in another interventional clinical trial within the past 3 months.
* Inability to complete study procedures or follow-up due to cognitive, physical, or social reasons.

Where it's running

• The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Haochen Sun — Jiangsu Province Nanjing Brain Hospital
• Study coordinator: Haochen Sun, MD
• Email: 735690822@qq.com
• Phone: +86-025-82296261

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.