Remote ischemic conditioning device for Parkinson's (NCT07299240)
Can arm cuff improve insomnia
- Trial ID
- NCT07299240
- Official Title
- Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease: a Randomized, Single-blind, Sham-controlled Clinical Study
- Goal
- Can arm cuff improve insomnia
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Jiangsu Province Nanjing Brain Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 48 participants
- Conditions
- Parkinson Disease (PD), Insomnia
- Interventions
- Remote ischemic conditioning device, Sham remote ischemic conditioning
Summary For Families
The goal is to find out whether brief arm cuff treatments that repeatedly stop and restart blood flow can improve insomnia and other non-motor problems in people with Parkinson's disease. The approach uses an inflatable cuff on the arm inflated to high pressure (active) or low pressure (sham) twice a day for 7 days, given in addition to each person’s usual Parkinson's medicines; prior work suggests this may change immune signals, circulating factors, brain activity, and the body clock. Sleep will be measured with questionnaires, sleep diaries and overnight sleep studies, and the study will also do brain electrical recordings, functional magnetic resonance imaging, eye imaging of the retina, and blood tests to explore how it might work. The study plans to enroll 48 people aged 50 to 70 who have Parkinson's for 5 years or less, are in early-to-moderate stages, have diagnosable insomnia, and are on a stable medication plan.
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
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "* on a stable regimen of antiparkinsonian medications for at least 4 weeks prior to enrollment, with no expected dose changes during the study period")
- Time since diagnosis: Diagnosed within the last 5 years (criteria text: "* disease duration <= 5 years")
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 NCT07299240. It is the one about "Can arm cuff improve 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? The listing already answers this: You will have two nights of polysomnography before treatment, receive RIC or sham RIC twice daily for 7 consecutive days, have repeat assessments after the 7-day intervention, and a further clinical and neurophysiological assessment approximately 21 days after RIC ends. Ask the coordinator to confirm it still applies.
- 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 Remote ischemic conditioning device. The goal is to find out whether brief arm cuff treatments that repeatedly stop and restart blood flow can improve insomnia and other non-motor problems in people with Parkinson's disease. The approach uses an inflatable cuff on the arm inflated to high pressure (active) or low pressure (sham) twice a day for 7 days, given in addition to each person’s usual Parkinson's medicines; prior work suggests this may change immune signals, circulating factors, brain activity, and the body clock. Sleep will be measured with questionnaires, sleep diaries and overnight sleep studies, and the study will also do brain electrical recordings, functional magnetic resonance imaging, eye imaging of the retina, and blood tests to explore how it might work. The study plans to enroll 48 people aged 50 to 70 who have Parkinson's for 5 years or less, are in early-to-moderate stages, have diagnosable insomnia, and are on a stable medication plan.
- Who can participate?
- Participants must be between 50 Years and 70 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.
- How many visits does this trial involve?
- You will have two nights of polysomnography before treatment, receive RIC or sham RIC twice daily for 7 consecutive days, have repeat assessments after the 7-day intervention, and a further clinical and neurophysiological assessment approximately 21 days after RIC ends.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.