40 Hz flicker light device for Parkinson's (NCT07323121)
Studying flickering light for insomnia
- Trial ID
- NCT07323121
- 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
- Goal
- Studying flickering light for insomnia
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Jiangsu Province Nanjing Brain Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease, Insomnia
- Interventions
- 40 Hz flicker light device, 100 Hz flicker light 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.
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")
Locations
- The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road, Nanjing, Jiangsu, China
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.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying 40 Hz flicker light device. 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.
- Who can participate?
- Participants must be between 50 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.