40 Hz flicker light device: A visual stimulation device delivering flicker light at 40 Hz. Participants assigned to this intervention receive 30 minutes of 40 Hz flicker light stimulation every night at bedtime for 7 consecutive days, in addition to their stable antiparkinsonian medication. Device parameters, including light intensity and distance, are adjusted according to the protocol to ensure safety and comfort.
100 Hz flicker light device: A visual stimulation device delivering 100 Hz light (e.g., steady or low-frequency light) with similar appearance and intensity as the 40 Hz device. Participants assigned to this intervention receive 30 minutes of control light exposure every night at bedtime for 7 consecutive days, in addition to their stable antiparkinsonian medication.
Study summary
This randomized, single-blind, controlled clinical trial aims to evaluate the efficacy and safety of 40 Hz flicker light stimulation for insomnia in patients with Parkinson's disease (PD). Patients with PD and clinically significant insomnia will be randomly assigned in a 1:1 ratio to receive either 40 Hz flicker light or control light for 30 minutes every night at bedtime for 7 consecutive days, in addition to standard antiparkinsonian treatment.
The primary objective is to determine whether 40 Hz flicker light stimulation improves PD-related insomnia as measured by Parkinson's Disease Sleep Scale-2 (PDSS-2). Secondary objectives include evaluating changes in polysomnography-derived sleep parameters, subjective sleep quality, and other non-motor symptoms, as well as assessing the safety and tolerability of the intervention.
This registration specifically covers the Parkinson's disease insomnia cohort of a larger, previously approved multi-cohort protocol that also includes healthy volunteers and primary insomnia patients.
Eligibility
Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score (0-60 points; higher scores indicate worse sleep disturbance). — Baseline and Day 7 The Parkinson's Disease Sleep Scale-2 (PDSS-2) is a 15-item questionnaire assessing nocturnal symptoms in Parkinson's disease. Each item is scored from 0 to 4, yielding a total score from 0 to 60 points. Higher scores indicate more severe sleep disturbance. The outcome measure is the change in PDSS-2 total score from baseline to Day 7 after the intervention, and the between-group difference (40 Hz vs control) in mean change will be compared.
Trial sites (1)
Facility
City
Region
Status
The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road
Nanjing
Jiangsu
Recruiting
More Jiangsu Province Nanjing Brain Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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