40 Hz Flickering for Insomnia in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorJiangsu Province Nanjing Brain Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
40 Hz flicker light device
DeviceA 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
DeviceA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 40 Hz flicker light stimulationExperimental treatment 1 intervention
Group B: 100 Hz flicker light stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score (0-60 points; higher scores indicate worse sleep disturbance).
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.
Time frame
Baseline and Day 7Secondary outcomes
1
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score at follow-up (0-60 points; higher scores indicate worse sleep disturbance).
The Parkinson's Disease Sleep Scale-2 (PDSS-2) total score ranges from 0 to 60 points, with higher scores indicating more severe sleep disturbance. The outcome measure is the change in PDSS-2 total score from baseline to Day 7 and to Day 28, and the between-group differences (40 Hz vs control) in these changes will be analyzed.
Time frame
Baseline, Day 7, and Day 282
Change in Non-Motor Symptoms Scale (NMSS) total score (0-360 points; higher scores indicate more severe non-motor symptoms).
The Non-Motor Symptoms Scale (NMSS) is a clinician-rated instrument assessing the severity and frequency of non-motor symptoms in Parkinson's disease. The total score ranges from 0 to 360 points, with higher scores indicating more severe non-motor symptom burden. The outcome measure is the change in NMSS total score from baseline to Day 7 between the two groups.
Time frame
Baseline and Day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiangsu Province Nanjing Brain Hospital
Lead sponsor
The Eye Hospital of Wenzhou Medical University
Collaborator
Source ClinicalTrials.gov