40 Hz Flickering for Insomnia in Parkinson's Disease
Recruiting · NCT07323121 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu Province Nanjing Brain Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road - Nanjing, Jiangsu, China