Flickering Light Device Tested for Sleep Problems in Parkinson's Disease
Tests a 40 Hz flickering light device for insomnia in people with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: 40 Hz Flickering for Insomnia in Parkinson's Disease
Key facts
- Where
- Nanjing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Source: NCT07323121, who can take part
Where in China
- The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou RoadNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Province Nanjing Brain Hospital
- Trial code
- NCT07323121
- Record updated
- 28 July 2026
- Original description
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.Read full original descriptionShow less
Randomized, Single-blind, Controlled Study of 40 Hz Flickering Stimulation for Insomnia and Other Non-motor Symptoms in Patients With Parkinson's Disease
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.
Inclusion: 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: 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.