--- title: Studying flickering light for insomnia nct_id: NCT07323121 phase: NA status: RECRUITING sponsor: Jiangsu Province Nanjing Brain Hospital study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07323121" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07323121" last_fetched: "2026-07-28T14:00:57.548Z" source: "Parkinson's Pathways (curated)" --- # Studying flickering light for insomnia **Goal (in five words):** Studying flickering light for insomnia **Official Title:** Randomized, Single-blind, Controlled Study of 40 Hz Flickering Stimulation for Insomnia and Other Non-motor Symptoms in Patients With Parkinson's Disease **Trial ID:** [NCT07323121](https://clinicaltrials.gov/study/NCT07323121) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Jiangsu Province Nanjing Brain Hospital - **Target Enrollment:** 30 participants - **Start Date:** 2026-01-01 - **Completion Date:** 2026-12-31 - **Conditions:** Parkinson Disease, Insomnia - **Interventions:** 40 Hz flicker light device, 100 Hz flicker light device - **Intervention Types:** DEVICE ## Summary For Families Goal: to find out whether using a 40 cycles-per-second flickering light at bedtime can improve insomnia in people with Parkinson's disease, measured mainly by the Parkinson's Disease Sleep Scale-2. Approach: participants will sit with a dedicated light that flickers at 40 times per second for 30 minutes each night for seven nights, while continuing their usual Parkinson's medicines; researchers think the light may change brain rhythms linked to sleep, chemical balance, and the brain's clearance system, and they will compare the 40 Hz light to a similar non-40 Hz control light. Eligibility: ages 50 to 75, Parkinson's diagnosis for 10 years or less with mild-to-moderate symptoms when on medication, clinically significant insomnia (Parkinson's Disease Sleep Scale-2 score of 18 or higher or meeting insomnia criteria), and a stable Parkinson's medication plan for at least four weeks. ## What This Actually Involves **Placebo** _(From the protocol)_: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio. **Visits** _(Ask the coordinator)_: Ask the coordinator how many in-person visits the study involves, how long each one takes, and over what total period. **Procedures** _(From the protocol)_: - Questionnaires & surveys (Non-invasive) > "Clinical assessments will include PD-specific sleep scales, particularly the Parkinson's Disease Sleep Scale-2 (PDSS-2), general sleep questionnaires such as the Pittsburgh Sleep Quality Index (PSQI), and sleep diaries." **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## Eligibility at a Glance Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call. - **Disease stage:** Hoehn and Yahr stage 1 to 3 - **Time since diagnosis:** Diagnosed within the last 10 years (criteria text: "* disease duration <= 10 years and hoehn and yahr stage <= 3 in the "on" state") ## Eligibility - **Minimum age:** 50 Years - **Maximum age:** 75 Years - **Sex:** ALL ### Full Criteria ``` 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. ``` ## Locations (1) - The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road, Nanjing, Jiangsu, China _(32.0617, 118.7778)_ - Haochen Sun, MD, (CONTACT), +86-025-82296261, 735690822@qq.com ## Central Contacts - Haochen Sun, MD, (CONTACT), +86-025-82296261, 735690822@qq.com ## Making Contact: How to Call This Study Site ### Who to ask for Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study. ### What to say It is fine to read this out loud, word for word: > Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07323121. It is the one about "Studying flickering light for insomnia". Could I speak with the study coordinator about taking part? If you are calling for a family member, use their name and mention that you help with their care. ### What they will ask you - The year of diagnosis - Current medications and their doses - Other health conditions - Any procedures already done, such as deep brain stimulation (DBS) - How far you are able to travel for study visits - Whether a care partner can come to visits with you ### What to have ready - A written list of current medications and doses - Your neurologist's name and phone number - The diagnosis date. The year is enough. - A recent visit summary from the neurologist, if you have one ### What to ask them - How many visits are there, and how long does each visit take? - Is travel, parking, or my time reimbursed? - Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio. - Would I need to stop or pause any of my current medications? - What happens when the study ends? Could I stay on the treatment if it helps? ### What to expect - Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal. - Many callers do not end up joining. Screening out is common and is not a judgment about you or your health. - Asking questions commits you to nothing. You can stop the process at any point. --- *Canonical: https://parkinsonspathways.com/trial/NCT07323121* *HTML version: https://parkinsonspathways.com/trial/NCT07323121* *Source data: https://clinicaltrials.gov/study/NCT07323121*